Airway Management in Singers: A Cross-sectional Survey.

OBJECTIVE: To review and establish current practices regarding airway management in vocal professionals undergoing surgery. STUDY DESIGN: Cross-sectional survey SETTING: The setting included practitioners that treat vocal professionals across international sub-specialty societies. SUBJECTS AND METHODS: A twenty-one-item survey was sent to practitioners that routinely treat vocal professionals including the American Broncho-Esophagological Association, European Laryngological Society, and 2017 Fall Voice Conference attendees. It included questions regarding the respondents' demographics, preferences for airway control in non-laryngeal and laryngeal surgery, and peri-operative management. RESULTS: Total respondents (n = 163): 82.8% were Laryngologists, 4.3 % were General Otolaryngologists, 3.1% were Head & Neck Oncologists, and 6.8% were Speech-Language Pathologists. One hundred twenty-five of the participants (76.7%) classified their experience with vocal professionals as 'extensive' or 'often.' For non-laryngeal surgery, there was a tendency towards laryngeal mask airway (53.1%) over endotracheal intubation (46.9%). For professional singers, a smaller endotracheal tube was recommended. Size varied based on sex. For males, 88.5% recommended a tube ≤7.0 in non-singers; 98.2% recommended a tube ≤7.0 in singers. In females 76.1% recommended a tube ≤6.0 for non-singers; 94.6 % recommended a size ≤6.0 in a female singer. For laryngeal surgery, 14% of providers personally intubated patients over 90% of the time. Of the providers who work with trainees, 60.5% did not allow resident intubation. CONCLUSION: Objective data regarding precautions in airway management of professional voice users is scarce. This is the largest survey to date on current practices. Survey results indicate that smaller ETTs are preferred for singers, and that more experienced practitioners are preferred for the intubation.

Low Pressure Low Frequency Jet Ventilation: Techniques, Safety and Complications.

OBJECTIVE: Manual jet ventilation is a specialized oxygenation and ventilation technique that is not available in all facilities due to lack of technical familiarity and fear of complications. The objective is to review our center's 15 year experience with low pressure low frequency jet ventilation (LPLFJV). METHODS: Retrospective review of procedures utilizing LPLFJV from 2005 to 2019 were performed collecting patient demographic, surgery type and complications. Fisher exact test, Chi square, and t-test were used to determine statistical significance. RESULTS: Four hundred fifty-seven patients underwent a total of 891 microlaryngeal surgeries-279 cases for voice disorders, 179 for lesions, and 433 for airway stenosis. The peak jet pressure for all cases did not exceed 20 psi and average peak pressure for the last 100 procedures in this case series was 14.9 ± 4.6 psi. The average lowest oxygen saturation for all cases was 95% ± 0.6%. Brief intubation was required in 154 cases (17%). Surgical duration was significantly longer for cases requiring intubation P < .001. The need for intubation was not associated with smoking or cardiopulmonary disease, but was strongly associated with body mass index (BMI). Intubation rates were 7% for normal weight (BMI < 25, N = 216), 13% for overweight (BMI 25-30, N = 282), 24% for obese (BMI 30-40, N = 342), and 37% for morbidly obese (BMI > 40, N = 52) patients. Three patients developed respiratory distress in the recovery unit and 2 patients required intubation. CONCLUSION: LPLFJV assisted by intermittent endotracheal intubation is an exceedingly safe and effective intraoperative oxygenation and ventilationmodality for a broad variety of laryngeal procedure.

Two probes and better than one: Development of a psychometrically reliable variant of the attentional probe task.

Cognitive models contend that attentional bias to negative information contributes to elevated anxiety vulnerability and dysfunction. The most common approach for assessing such bias is the attentional probe task. In this task, participants are presented with stimulus pairs, usually comprising a negative and benign member. A single visual probe subsequently appears in the locus where either stimulus was displayed, and remains on-screen until the participant identifies it. Attentional distribution is inferred from relative speed to identify probes in the location of each stimulus. Recently, investigators have raised concerns about the psychometric reliability of this attentional probe task as a measure of attentional bias, and have called for the development of new tasks with the capacity to more reliably assess variation in biased attentional responding to target stimuli. In response to this call, we report the development of a new dual probe attentional assessment approach, in which two probes are briefly presented on each trial, and attentional distribution is inferred from relative accuracy to identify probes appearing in each screen location. Across four studies, we show that this dual probe approach demonstrates much higher psychometric reliability than the single probe task, and can sensitively detect anxiety-linked attentional bias to negative information.

Laryngeal complications of COVID-19.

OBJECTIVE: To describe and visually depict laryngeal complications in patients recovering from coronavirus disease 2019 (COVID-19) infection along with associated patient characteristics. STUDY DESIGN: Prospective patient series. SETTING: Tertiary laryngology care centers. SUBJECTS AND METHODS: Twenty consecutive patients aged 18 years or older presenting with laryngological complaints following recent COVID-19 infection were included. Patient demographics, comorbid medical conditions, COVID-19 diagnosis dates, symptoms, intubation, and tracheostomy status, along with subsequent laryngological symptoms related to voice, airway, and swallowing were collected. Findings on laryngoscopy and stroboscopy were included, if performed. RESULTS: Of the 20 patients enrolled, 65% had been intubated for an average duration of 21.8 days and 69.2% requiring prone-position mechanical ventilation. Voice-related complaints were the most common presenting symptom, followed by those related to swallowing and breathing. All patients who underwent flexible laryngoscopy demonstrated laryngeal abnormalities, most frequently in the glottis (93.8%), and those who underwent stroboscopy had abnormalities in mucosal wave (87.5%), periodicity (75%), closure (50%), and symmetry (50%). Unilateral vocal fold immobility was the most common diagnosis (40%), along with posterior glottic (15%) and subglottic (10%) stenoses. 45% of patients underwent further procedural intervention in the operating room or office. Many findings were suggestive of intubation-related injury. CONCLUSION: Prolonged intubation with prone-positioning commonly employed in COVID-19 respiratory failure can lead to significant laryngeal complications with associated difficulties in voice, airway, and swallowing. The high percentage of glottic injuries underscores the importance of stroboscopic examination. Otolaryngologists must be prepared to manage these complications in patients recovering from COVID-19. LEVEL OF EVIDENCE: IV.

A Network Comparative Meta-analysis of Percutaneous Dilatational Tracheostomies Using Anatomic Landmarks, Bronchoscopic, and Ultrasound Guidance Versus Open Surgical Tracheostomy.

BACKGROUND: Several different tracheostomy techniques (percutaneous and surgical) have been studied extensively in previous direct pairwise meta-analyses. However, a network comparative meta-analysis comparing all has not been conducted before. OBJECTIVE: We sought to compare three percutaneous dilatational tracheostomy techniques with open surgical tracheostomy technique (performed in the operating room or in the intensive care unit by bedside) in terms of their association with procedure-related major complications and procedure time. DATA SOURCES: We searched PubMed and Cochrane register of randomized active comparator trials. DATA EXTRACTION AND SYNTHESIS: A network comparative meta-analysis was performed in Stata using frequentist methodology. Major complications were defined as a composite of a priori-selected procedure-related complications. Tracheostomy techniques that did not require any direct bronchoscopic or ultrasonographic visualization of the entire procedure were grouped under the heading-anatomic landmark-based dilatational tracheostomy (ALDT). This along with bronchoscopic-guided dilatational tracheostomy (BDT), ultrasound-guided (UDT), and surgical tracheostomy (SGT) were compared with each other using network meta-analysis in Stata after all major assumptions (similarity, transitivity, and consistency) for performing a network were met. Log odds ratio (and standard errors) of the comparison of major complications between any two tracheostomy techniques (using indirect estimates) was statistically insignificant. Pairwise meta-analysis showed significant differences in procedure times between SGT and ALDT [mean difference: 9.96 min (SE 3.18)] and between SGT and BDT [15.67 min (SE 3.85)]. The indirect network meta-analysis comparing one versus the other also showed a statistically significant time difference between surgical tracheostomy when compared with every other technique. CONCLUSIONS: The results of our network meta-analysis show that all tracheostomy techniques are comparable with respect to associated procedure-related complications, but all three percutaneous techniques take far less procedure time compared to the surgical tracheostomy.

Osteoradionecrosis of the sternoclavicular joint after laryngopharyngeal radiation.

OBJECTIVES: Adequate treatment of laryngopharyngeal malignancy often incorporates radiation therapy. Structures surrounding laryngopharynx exposed to traditional radiation doses are susceptible to posttreatment toxicity. Among poorly understood sequelae is the rare manifestation of sternoclavicular joint (SCJ) osteoradionecrosis (ORN). METHODS: Three institutional encounters prompted a comprehensive literature search, generating three published case reports. Systematic extraction and analysis (n = 6) of demographics, cancer history, comorbidities, ORN presentation, imaging, and management established the largest series to investigate this pathology. RESULTS: Patients were males (6), 54 to 70 years old, smokers (4), with Hypertension/dyslipidemia, myocardial infarction/coronary artery disease, second primary (2), diabetes mellitus (1), and myelofibrosis(1). Four underwent total laryngectomy, one primary, three as salvage. Five patients had concurrent chemoradiation (≥70 Gy). All patients presented with swollen, tender neck wounds concerning for persistent/recurrent malignancy. Computed tomography (CT) demonstrated bone erosion (5 of 5) and increased bone scan uptake (2 of 2). All responded to surgical exploration with drainage alone (1), sequestrectomy (2), or bone resection with synovectomy (3). Complete healing took 2 months to 3 years. One unrelated patient death occurred before control of ORN was achieved. DISCUSSION: Given varied patient characteristics, synergistic risk factors exist that alter bone radiation threshold, resulting in irreversible ischemic damage and osteoradionecrosis. Vascular susceptibility and inability to repair may regulate that threshold. Understanding this relationship will facilitate early detection and intervention. CONCLUSION: Integrating cases of sternoclavicular joint ORN promotes awareness of atypical laryngopharyngeal radiation complications, elucidates contributing factors, educates physicians on presentation and management, and provides a platform for prospective investigation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:865-870, 2019.

Body Mass Index and Parotidectomy Outcomes.

Multiple specialties have demonstrated increased risk of certain postoperative complications in patients with an increased body mass index (BMI). The goal of this study was to understand the outcomes of patients undergoing parotidectomy with an increased BMI and to identify any other patient risk factors for postoperative complications. This study was a retrospective chart review of 432 patients. Patient variables collected included BMI, age, gender, history of diabetes mellitus, type of parotidectomy, and pathology. Outcomes reviewed included facial nerve weakness, hematoma or seroma formation, and wound infection. The results showed that BMI had no statistically significant effect on complications. However, patients undergoing a total parotidectomy, malignant pathology, and patients with a history of diabetes mellitus had significantly more postoperative facial weakness. In conclusion, BMI does not influence postoperative complications in patients undergoing parotidectomy. Patients with diabetes, those undergoing total parotidectomies, and patients with malignant pathology have significantly more facial weakness and should be counseled accordingly.

Impact of vocal fold augmentation and laryngoplasty on dyspnea in patients with glottal incompetence.

OBJECTIVES/HYPOTHESIS: Given that the vocal folds are active organs of respiration, reports of dyspnea in the context of glottic insufficiency are not uncommon. We hypothesize that improved glottal closure via framework surgery or vocal fold augmentation improves dyspnea symptoms. STUDY DESIGN: Retrospective review. METHODS: Charts of patients undergoing procedures to correct glottal insufficiency, either via vocal fold augmentation (VFA) or medialization laryngoplasty (ML) between December 2012 and September 2015 were reviewed (n = 189). Modified Borg Dyspnea Scale (MBDS) and Modified Medical Research Council Dyspnea Scale (MMRCDS) data were collected before and after intervention. Age, body mass index (BMI), and sex, as well as pulmonary and cardiac comorbidities were considered. Subgroup analysis was performed on individuals with subjective dyspnea prior to intervention. RESULTS: For the entire cohort, differences in the MMRCDS and MBDS were not statistically different pre- and postintervention (P = .20 and P = .12, respectively). Patients with BMI <30 experienced more improvement on the MBDS (P = .03). Both the MMRCDS and MMBDS improved post-procedure (P = .001 and P = .001, respectively) in patients reporting dyspnea prior to intervention. CONCLUSIONS: Patients with glottic insufficiency and dyspnea prior to intervention to improve glottic closure had a significant reduction in dyspnea following treatment. Conversely, subjects without complaints of dyspnea prior to intervention had variable outcomes with regard to dyspnea symptoms. Additionally, based on data from the entire cohort, VFA or ML did not worsen dyspnea symptoms. These data may assist in counseling and/or selection of patients considered for procedures to improve glottic closure. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:427-429, 2018.

Changes in Peak Airflow Measurement During Maximal Cough After Vocal Fold Augmentation in Patients With Glottic Insufficiency.

Importance: Compromised cough effectiveness is correlated with dysphagia and aspiration. Glottic insufficiency likely yields decreased cough strength and effectiveness. Although vocal fold augmentation favorably affects voice and likely improves cough strength, few data exist to support this hypothesis. Objective: To assess whether vocal fold augmentation improves peak airflow measurements during maximal-effort cough following augmentation. Design, Setting, and Participants: This case series study was conducted in a tertiary, academic laryngology clinic. Participants included 14 consecutive individuals with glottic insufficiency due to vocal fold paralysis, which was diagnosed via videostrobolaryngoscopy as a component of routine clinical examination. All participants who chose to proceed with augmentation were considered for the study whether office-based or operative augmentation was planned. Postaugmentation data were collected only at the first follow-up visit, which was targeted for 14 days after augmentation but varied on the basis of participant availability. Data were collected from June 5, 2014, to October 1, 2015. Data analysis took place between October 2, 2015, and March 3, 2017. Main Outcomes and Measures: Peak airflow during maximal volitional cough was quantified before and after vocal fold augmentation. Participants performed maximal coughs, and peak expiratory flow during the maximal cough was captured according to American Thoracic Society guidelines. Results: Among the 14 participants (7 men and 7 women), the mean (SD) age was 62 (18) years. Three types of injectable material were used for vocal fold augmentation: carboxymethylcellulose in 5 patients, hyaluronic acid in 5, and calcium hydroxylapatite in 4. Following augmentation, cough strength increased in 11 participants and decreased cough strength was observed in 3. Peak airflow measurements during maximal cough varied from a decrease of 40 L/min to an increase of 150 L/min following augmentation. When preaugmentation and postaugmentation peak airflow measurements were compared, the median improvement was 50 L/min (95% CI, 10-75 L/min; P = .01). Immediate peak airflow measurements during cough collected within 30 minutes of augmentation varied when compared with measurements collected at follow-up (103-380 vs 160-390 L/min). Conclusions and Relevance: Peak airflow during maximal cough may improve with vocal fold augmentation. Additional assessment and measurements are needed to further delineate which patients will benefit most regarding their cough from vocal fold augmentation.

Treatment of Neurogenic Cough with Tramadol: A Pilot Study.

This study employs validated cough assessment tools to prospectively determine the impact of tramadol on cough severity and quality of life in subjects with neurogenic cough. The study was a prospective case series with planned data collection at a tertiary care academic medical center laryngology practice. Sixteen consecutive collected subjects with neurogenic cough prospectively completed pre- and posttreatment validated cough assessment tools, the cough severity index (CSI) and Leicester Cough Questionnaire (LCQ). All subjects in the study reported at least some improvement in their cough symptoms. In a Wilcoxon signed rank test that compared paired results, CSI scores improved from 23 to 14 and LCQ scores improved from 74 to 103 ( P = .003 and P = .005, respectively). This small preliminary assessment suggests that tramadol warrants additional evaluation as a treatment for neurogenic cough.

Adjuvant Human Papillomavirus Vaccination for Secondary Prevention: A Systematic Review.

Importance: Human papillomavirus (HPV) vaccination is recommended for children and younger adults but not older adults or those with prior HPV exposure, leaving a large portion of the population at risk for HPV-mediated disease. Emerging data suggest a possible role for vaccination as an adjuvant treatment for individuals with HPV-related clinical disease. Objective: To systematically review the literature regarding HPV vaccination for secondary disease prevention after treatment of active clinical disease across disease sites to serve as a platform for the management of HPV-related disease of the head and neck. Evidence Review: A systematic search from August 3 to 21, 2015, of the PubMed, MEDLINE, EMBASE, CINAHL, Cochrane Library, Web of Science, Biosis Citation Index, Current Contents Connect, Scientific Library Online, and Global Health databases used PRISMA guidelines to identify 326 relevant articles related to adjuvant use of HPV vaccination. Primary search terms were (HPV vaccine OR human papillomavirus vaccine OR papillomarvirus vaccines OR alphapapillomavirus vaccine) AND (HPV OR human papillomavirus OR alphapapillomavirus OR papillomaviridae OR virus warts OR wart virus) AND (recurrence OR relapse OR reoccurrence OR recurrences OR relapses OR relapsing). Forty-five full texts in English were reviewed, with 19 articles included in the final review. In some studies, subpopulations of individuals with HPV DNA positivity and/or seropositivity were extracted for inclusion. Included studies were assessed for bias and separated based on the presence of active clinical disease or HPV DNA positivity or seropositivity. Findings: Nineteen studies with 22 474 unique patients were included in the review. When HPV vaccination was used as an adjuvant treatment for active clinical disease, 9 of 12 studies reported decreased disease recurrence, decreased disease burden, or increased intersurgical interval. In contrast, none of the 7 studies of vaccination in individuals with HPV DNA positivity and/or seropositivity without clinical disease reported improved outcomes. Conclusions and Relevance: Differences between adjuvant vaccination in HPV-mediated clinical disease and vaccination in HPV DNA-positive and/or HPV-seropositive populations posit underlying differences in disease and immune processes. These data suggest that additional evaluation of adjuvant HPV vaccination in individuals with active clinical disease is warranted.

Imiquimod Injection to Rabbit Vocal Folds: A Preliminary, Preclinical Investigation.

Objective Given the recalcitrant nature of recurrent respiratory papillomatosis, targeted therapies to reduce disease burden are fundamental to improved patient care paradigms. We seek to demonstrate the safety of imiquimod injection into vocal fold mucosa by evaluating the degree of laryngeal edema, histopathologic changes to vocal fold structure, and serologic interferon α (IFNα) levels following injection. Study Design Preclinical. Setting Academic institution. Subjects and Methods Six New Zealand White rabbits underwent unilateral injection of 100 µg of sterile imiquimod (1 µg/µL), with 100 µL of normal saline injected into the contralateral vocal fold. Direct laryngoscopy was performed on days 3, 7, and 30 following injection. Larynges from 3 rabbits were harvested on postinjection day 7 for histologic analysis. The remaining 3 rabbit larynges were harvested on day 30. Serial serum samples were drawn for IFNα quantification via immunoassay. Results No signs of respiratory distress were observed at any point. Vocal fold appearance was not clinically divergent between imiquimod and control conditions via serial direct laryngoscopic evaluation. No inflammatory lesions or scarring were identified following injection. Histology showed no signs of acute inflammatory processes or changes in the control or imiquimod injection groups. Serum IFNα increased at days 3 and 7 following imiquimod injection ( P < .0001 and P = .0368, respectively), before returning to baseline by day 14. Conclusions Vocal fold imiquimod injection did not result in notable morbidity in this preclinical model. However, serum IFNα concentrations increased transiently. These data are critical to advance the therapeutic utility of this compound, particularly in the setting of recurrent respiratory papillomatosis.

Development of an in vivo model of laryngeal burn injury.

OBJECTIVES/HYPOTHESIS: Inhalation injury significantly increases morbidity and mortality in burn patients. Approximately one in five burn patients have acute injury to the larynx, trachea, and/or lungs-and as many as 70% have long-term laryngeal abnormalities. Although inhalation injury to the lung has been studied extensively, no models exist to study these insults to the larynx. As such, we developed an in vivo rabbit model to create precise and reproducible laryngeal burn with resultant tissue damage as a foundation for interventional studies. METHODS: Following tubeless tracheotomy, a custom temperature-control device was employed to apply heated air (70°C-80°C, 150°C-160°C, or 310°C-320°C) ± smoke derived from unbleached cotton to the larynx, endoscopically, minimizing adjacent tissue damage in six rabbits. Pain, nutrition, and level of activity were monitored. Direct laryngoscopy and histological examination were performed 24 hours following insult. RESULTS: All animals survived injury with appropriate pain control; oral intake was initiated and all were adequately ventilating via tracheostomy. Burn sequelae were noted under direct visualization 24 hours after injury, and graded levels of edema and tissue damage were observed as a function of temperature. Edema obstructed true vocal fold visualization at increased temperatures. These injury patterns correlated with graded tissue damage on histology. CONCLUSION: We created an in vivo model of laryngeal burn injury employing a custom burn device resulting in graded tissue injury. This model is critical for investigation of the mechanisms underlying burn injury, and ultimately, the development and evaluation of therapies for this challenging population. LEVEL OF EVIDENCE: NA Laryngoscope, 127:186-190, 2017.

Dynamic nanomechanical analysis of the vocal fold structure in excised larynges.

OBJECTIVES/HYPOTHESIS: Quantification of clinical outcomes after vocal fold (VF) interventions is challenging with current technology. High-speed digital imaging and optical coherence tomography (OCT) of excised larynges assess intact laryngeal function, but do not provide critical biomechanical information. We developed a protocol to quantify tissue properties in intact, excised VFs using dynamic nanomechanical analysis (nano-DMA) to obtain precise biomechanical properties in the micrometer scale. STUDY DESIGN: Experimental animal study. METHODS: Three pig larynges were bisected in the sagittal plane, maintaining an intact anterior commissure, and subjected to nano-DMA at nine locations with a 250-µm flat-tip punch and frequency sweep load profile (10-105 Hz, 1,000 µN peak force) across the free edge of the VF and inferiorly along the conus elasticus. RESULTS: Storage, loss, and complex moduli increased inferiorly from the free edge. Storage moduli increased from a mean of 32.3 kPa (range, 6.5-55.38 kPa) at the free edge to 46.3kPa (range, 7.4-71.6) 5 mm below the free edge, and 71.4 kPa (range, 33.7-112 kPa) 1 cm below the free edge. Comparable values were 11.6 kPa (range, 5.0-20.0 kPa), 16.7 kPa (range, 5.7-26.8 kPa), and 22.6 kPa (range, 9.7-38.0 kPa) for loss modulus, and 35.7 kPa (range, 14.4-56.4 kPa), 50.1 kPa (range, 18.7-72.8 kPa), and 75.4 kPa (range, 42.0-116.0 kPa) for complex modulus. Another larynx repeatedly frozen and thawed during technique development had similarly increased storage, loss, and complex modulus trends across locations. CONCLUSIONS: Nano-DMA of the intact hemilarynx provides a platform for quantification of biomechanical responses to a myriad of therapeutic interventions to complement data from high-speed imaging and OCT. LEVEL OF EVIDENCE: NA Laryngoscope, 127:E225-E230, 2017.

Endoscope-assisted approach to excision of branchial cleft cysts.

OBJECTIVES/HYPOTHESIS: The purpose of this study is to describe an endoscope-assisted surgical technique for the excision of branchial cleft cysts and compare it to the standard approach. STUDY DESIGN: Retrospective case series review. METHODS: Twenty-seven cases described as branchial cleft excisions performed by a single surgeon at one academic medical center were identified between 2007 and 2014. Twenty-five cases (8 endoscopic, 17 standard approach) were included in the study. Cases were excluded if final pathology was malignant. Patient charts were reviewed, and two techniques were compared through analysis of incision size, operative time, and surgical outcomes. RESULTS: This study showed that the length of incision required for the endoscopic approach (mean = 2.13 ± 0.23) was significantly less than that of the standard approach (mean = 4.10 ± 1.46, P = 0.008) despite the fact that there was no significant difference in cyst size between the two groups (P = 0.09). The other variables examined, including operative time and surgical outcomes, were not significantly different between the two groups. CONCLUSION: This transcervical endoscope-assisted approach to branchial cleft cyst excision is a viable option for uncomplicated cases. It provides better cosmetic results than the standard approach and does not negatively affect outcomes, increase operative time, or result in recurrence. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:1339-1342, 2016.

A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy.

UNLABELLED: Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI) training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15) and waitlist control arms (n = 16). Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon's randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001). Specifically, there were significant improvements in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. Our BCI-based system shows promise in improving memory and attention in healthy elderly, and appears to be safe, user-friendly and acceptable to senior users. Given the efficacy signal, a phase III trial is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT01661894.

A brain-computer interface based attention training program for treating attention deficit hyperactivity disorder.

UNLABELLED: Attention deficit hyperactivity disorder (ADHD) symptoms can be difficult to treat. We previously reported that a 20-session brain-computer interface (BCI) attention training programme improved ADHD symptoms. Here, we investigated a new more intensive BCI-based attention training game system on 20 unmedicated ADHD children (16 males, 4 females) with significant inattentive symptoms (combined and inattentive ADHD subtypes). This new system monitored attention through a head band with dry EEG sensors, which was used to drive a feed forward game. The system was calibrated for each user by measuring the EEG parameters during a Stroop task. Treatment consisted of an 8-week training comprising 24 sessions followed by 3 once-monthly booster training sessions. Following intervention, both parent-rated inattentive and hyperactive-impulsive symptoms on the ADHD Rating Scale showed significant improvement. At week 8, the mean improvement was -4.6 (5.9) and -4.7 (5.6) respectively for inattentive symptoms and hyperactive-impulsive symptoms (both p<0.01). Cohen's d effect size for inattentive symptoms was large at 0.78 at week 8 and 0.84 at week 24 (post-boosters). Further analysis showed that the change in the EEG based BCI ADHD severity measure correlated with the change ADHD Rating Scale scores. The BCI-based attention training game system is a potential new treatment for ADHD. TRIAL REGISTRATION: ClinicalTrials.gov NCT01344044.

Effectiveness of a brain-computer interface based programme for the treatment of ADHD: a pilot study.

Majority of children with attention deficit hyperactivity disorder (ADHD) have significant inattentive symptoms. We developed a progressive series of activities involving brain-computer interface-based games which could train users to improve their concentration. This pilot study investigated if the intervention could be utilized in children and if it could improve inattentive symptoms of ADHD. Ten medication-naive children aged 7 to 12 diagnosed with ADHD (combined or inattentive subtypes) received 20 sessions of therapy over a 10-week period. They were compared with age- and gendermatched controls. Both parent and teacher-rated inattentive score on the ADHD Rating Scale-IV improved more in the intervention group. A larger scale trial is warranted to further investigate the efficacy of our treatment programme in treating ADHD.