A study protocol for an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using portable transcranial electrical stimulation and internet-based behavioral therapy for major depression disorders: The PSYLECT study.

BACKGROUND: Transcranial electrical stimulation (tES) is considered effective and safe for depression, albeit modestly, and prone to logistical burdens when performed in external facilities. Investigation of portable tES (ptES), and potentiation of ptES with remote psychological interventions have shown positive, but preliminary, results. RESEARCH DESIGN: We report the rationale and design of an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using ptES and internet-based behavioral therapy (iBT) for major depressive disorder (MDD) (NCT04889976). METHODS: We will evaluate the efficacy, safety, tolerability and usability of (1) active ptES + active iBT ('double-active'), (2) active ptES + sham iBT ('ptES-only'), and (3) sham ptES + sham iBT ('double-sham'), in adults with MDD, with a Hamilton Depression Rating Scale - 17 item version (HDRS-17) score ≥ 17 at baseline, during 6 weeks. Antidepressants are allowed in stable doses during the trial. RESULTS: We primarily co-hypothesize changes in HDRS-17 will be greater in (1) 'double-active' compared to 'ptES-only,' (2) 'double-active' compared to 'double-sham,' and (3) 'ptES-only' compared to 'double-sham.' We aim to enroll 210 patients (70 per arm). CONCLUSIONS: Our results should offer new insights regarding the efficacy and scalability of combined ptES and iBT for MDD, in digital mental health.

Improvements on spatial coverage and focality of deep brain stimulation in pre-surgical epilepsy mapping.

Objective.Electrical stimulation mapping (ESM) of the brain using stereo-electroencephalography (SEEG) intracranial electrodes, also known as depth-ESM (DESM), is being used as part of the pre-surgical planning for brain surgery in drug-resistant epilepsy patients. Typically, DESM consists in applying the electrical stimulation using adjacent contacts of the SEEG electrodes and in recording the EEG responses to those stimuli, giving valuable information of critical brain regions to better delimit the region to resect. However, the spatial extension or coverage of the stimulated area is not well defined even though the precise electrode locations can be determined from computed tomography images.Approach.We first conduct electrical simulations of DESM for different shapes of commercial SEEG electrodes showing the stimulation extensions for different intensities of injected current. We then evaluate the performance of DESM in terms of spatial coverage and focality on two realistic head models of real patients undergoing pre-surgical evaluation. We propose a novel strategy for DESM that consist in applying the current using contacts of different SEEG electrodes (x-DESM), increasing the versatility of DESM without implanting more electrodes. We also present a clinical case where x-DESM replicated the full semiology of an epilepsy seizure using a very low-intensity current injection, when typical adjacent DESM only reproduced partial symptoms with much larger intensities. Finally, we show one example of DESM optimal stimulation to achieve maximum intensity, maximum focality or intermediate solution at a pre-defined target, and one example of temporal interference in DESM capable of increasing focality in brain regions not immediately touching the electrode contacts.Main results.It is possible to define novel current injection patterns using contacts of different electrodes (x-DESM) that might improve coverage and/or focality, depending on the characteristics of the candidate brain. If individual simulations are not possible, we provide the estimated radius of stimulation as a function of the injected current and SEEG electrode brand as a reference for the community.Significance.Our results show that subject-specific electrical stimulations are a valuable tool to use in the pre-surgical planning to visualize the extension of the stimulated regions. The methods we present here are also applicable to pre-surgical planning of tumor resections and deep brain stimulation treatments.

Transcranial Direct Current Stimulation in Patients with Anxiety: Current Perspectives.

Anxiety is one of the most prevalent and debilitating psychiatric conditions worldwide. Pharmaco- and psycho-therapies have been employed in the treatment of human anxiety to date. Yet, either alone or in combination, unsatisfactory patient outcomes are prevalent, resulting in a considerable number of people whose symptoms fail to respond to conventional therapies with symptoms remaining after intervention. The demand for new therapies has given birth to several noninvasive brain stimulation techniques. Transcranial direct current stimulation (tDCS) has arisen as a promising tool and has been proven to be safe and well tolerated for the treatment of many diseases, including chronic pain, depression, and anxiety. Here, reports of the use of tDCS in anxiety disorders in human patients were reviewed and summarized. A literature search was conducted in mid-2019, to identify clinical studies that evaluated the use of tDCS for the treatment of anxiety behavior. The PubMed, Web of Science, and Scielo and PsycInfo databases were explored using the following descriptors: "anxiety", "anxious behavior", "tDCS", and "transcranial direct current stimulation". Among the selected articles, considerable variability in the type of tDCS treatment applied in interventions was observed. Evidence shows that tDCS may be more effective when used in combination with drugs and cognitive behavioral therapies; however future large-scale clinical trials are recommended to better clarify the real effects of this intervention alone, or in combination with others.

Neurophysiological assessment of spinal cord injuries in dogs using somatosensory and motor evoked potentials.

Somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs) are non-invasive neurophysiological tests that reflect the functional integrity of sensory and motor pathways. Despite their extensive use and description in human medicine, reports in veterinary medicine are scarce. SSEPs are obtained via peripheral stimulation of sensory or mixed nerves; stimulation induces spinal and cortical responses, which are recorded when sensory pathways integrity is preserved. MEPs can be obtained via transcranial electrical or magnetic stimulation; in this case, thoracic and pelvic limb muscle responses are captured if motor pathways are preserved. This review describes principles, methodology and clinical applicability of SSEPs and MEPs in companion animal medicine. Potential interferences of anesthesia with SSEP and MEP recording are also discussed.

Transcranial Electrical Neuromodulation Based on the Reciprocity Principle.

A key challenge in multi-electrode transcranial electrical stimulation (TES) or transcranial direct current stimulation (tDCS) is to find a current injection pattern that delivers the necessary current density at a target and minimizes it in the rest of the head, which is mathematically modeled as an optimization problem. Such an optimization with the Least Squares (LS) or Linearly Constrained Minimum Variance (LCMV) algorithms is generally computationally expensive and requires multiple independent current sources. Based on the reciprocity principle in electroencephalography (EEG) and TES, it could be possible to find the optimal TES patterns quickly whenever the solution of the forward EEG problem is available for a brain region of interest. Here, we investigate the reciprocity principle as a guideline for finding optimal current injection patterns in TES that comply with safety constraints. We define four different trial cortical targets in a detailed seven-tissue finite element head model, and analyze the performance of the reciprocity family of TES methods in terms of electrode density, targeting error, focality, intensity, and directionality using the LS and LCMV solutions as the reference standards. It is found that the reciprocity algorithms show good performance comparable to the LCMV and LS solutions. Comparing the 128 and 256 electrode cases, we found that use of greater electrode density improves focality, directionality, and intensity parameters. The results show that reciprocity principle can be used to quickly determine optimal current injection patterns in TES and help to simplify TES protocols that are consistent with hardware and software availability and with safety constraints.