Protocol of a randomized controlled trial investigating Deep Brain Stimulation for MOtor symptoms in patients with Parkinson's disease DEmentia (DBS-MODE).

BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for disabling motor symptoms of Parkinson's disease (PD) that persist despite optimal pharmacological treatment. Currently, DBS is not performed if there is concomitant significant cognitive impairment based on concerns of cognitive deterioration, higher complication rate and less functional improvement. However, this has not been investigated so far. METHODS: A single center, prospective, randomized, open-label, blinded end-point (PROBE design) pilot clinical trial is being performed. Patients are eligible for the trial if they have PD dementia (PDD), are able to provide informed consent, and experience disabling motor response fluctuations, bradykinesia, dyskinesia, or painful dystonia, despite optimal pharmacological treatment. In total 44 patients will be randomized to either STN-DBS accompanied by best medical treatment (DBS group) or to best medical treatment alone (BMT group). The primary outcome measure is the change from baseline to 30 weeks on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale part III score in a standardized off-drug phase. The main secondary outcome measures consist of scales assessing cognitive aspects of daily living, neuropsychiatric symptoms and impulsive compulsive disorders. Additional secondary outcome measures include motor signs during on-drug phase, dyskinesia, motor fluctuations, cognitive performance, (severe) adverse events, treatment satisfaction, and caregiver burden. Patients will be followed during 52 weeks after randomization. DISCUSSION: The Deep Brain Stimulation for MOtor symptoms in patients with Parkinson's disease DEmentia (DBS-MODE) trial directly compares the effectiveness and safety of DBS with BMT in patients with PDD. TRIAL REGISTRATION: The DBS-MODE trial has been registered in the International Clinical Trial Registry Platform (NL9361) on the 24th of March 2021 ( https://trialsearch.who.int/Trial2.aspx?TrialID=NL9361 ).

Cognitive change after electroconvulsive therapy in mood disorders measured with the Montreal Cognitive Assessment.

OBJECTIVE: The Montreal Cognitive Assessment (MoCA) is a sensitive and clinically practical test but its usefulness in measuring long-term cognitive effects of ECT is unclear. Using the MoCA, we investigated short- and long-term global cognitive change in ECT-treated patients with a Major Depressive Episode (MDE). METHOD: We included 65 consecutive ECT-treated patients with MDE, in whom global cognitive functioning was assessed at baseline (T0); during ECT (before the third session; T1); and 1 week (T2), 3 months (T3), and 6 months (T4) after completion of the index course. Changes in MoCA (sub)scores were analyzed using linear mixed models and reliable change indices were computed to investigate individual changes in MoCA total scores. RESULTS: There was a significant effect of time on MoCA scores (F(4, 230.5) = 4.14, P = 0.003), with an improvement in global cognitive functioning from T3 compared to T1 and T2. At the individual level, 26% (n = 17) of patients showed a significantly worse cognitive functioning at T2 and 12% (n = 8) an improved cognitive functioning compared to T0. For T4, these percentages ameliorated to 8% and 18% respectively. CONCLUSION: No persistent global cognitive impairment induced by ECT was found at the group level using the MoCA. At the individual level, however, there was clear heterogeneity in the effects of ECT on cognitive functioning. The MoCA is a suitable tool to monitor short- and long-term global cognitive functioning in ECT-treated patients with MDE but in younger patients, potential ceiling effects must be taken into account.

ECT non-remitters: prognosis and treatment after 12 unilateral electroconvulsive therapy sessions for major depression.

BACKGROUND: Depressive disorder causes significant suffering in patients and caregivers worldwide. Electroconvulsive therapy (ECT) is a highly effective antidepressant treatment, but little is known about the prognosis and treatment of patients who do not achieve remission with ECT. We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions. METHODS: We conducted a retrospective, naturalistic follow-up study. Patients who had previously participated in a double-blind randomized controlled trial that compared brief pulse with ultra-brief pulse ECT and who had not achieved remission after 12 right unilateral (RUL) ECT sessions were selected for this study. We analysed the type of treatments received during the 6-month follow-up and studied the occurrence of remission and response. The primary outcome was remission, defined as a Montgomery-Åsberg Depression Rating Scale score <10. RESULTS: Eighty-one patients were randomized, of which 18 patients did not remit. Eight of these non-remitters achieved remission during follow-up (44.4%) while 7 did not achieve remission (38.9%). Remission data could not be retrieved for 3 patients (16.7%). Remission was achieved in 6 patients by a combination of continuing unilateral ECT with antidepressants or switching to bilateral ECT. LIMITATIONS: This is a retrospective study with only a small number of patients. Treatment after RUL ECT non-remission was not standardized. CONCLUSION: When patients with major depression do not achieve remission after 12 RUL ECT sessions, they have still a reasonable chance of remission within 6 months. Continuing ECT has the best chance of success.

Understanding electroconvulsive therapy-related anxiety: a prospective study.

AIMS OF STUDY: Although electroconvulsive therapy (ECT)-related anxiety is experienced by a significant proportion of patients, it remains understudied. Our aim was to study the course of ECT-related anxiety during ECT. METHODS: Seventy-four patients with unipolar or bipolar depression, referred for ECT, were included. ECT-related anxiety was assessed the morning before each ECT session using the ECT-related Anxiety Questionnaire (ERAQ). RESULTS: Female patients reported more anxiety than men (F(1,64.6) = 3.95, P = 0.05). Patients with a psychotic depression were more anxious before the start of ECT (F(64.8) = 4.57, P = 0.04), but experienced a significant decrease in ECT-related anxiety (t(63.9) = -3.63, P = 0.0006), whereas patients with a non-psychotic depression remained stable on anxiety during their ECT course (t(63,9) = 0.76, P = 0.45). In addition, we found a significant correlation between the decrease of ECT-related anxiety and the decrease of depression-severity (r = 0.35; P = 0.04). CONCLUSION: There are individual differences in ECT-related anxiety trajectories during ECT. Both female patients and patients with psychotic depression experienced more ECT-related anxiety before the start of ECT. The severity of ECT-related anxiety decreased significantly in patients with a psychotic depression, but remained stable in patients without a psychotic depression during ECT. In addition, patients who showed a stronger decrease in depression-severity also showed a stronger decrease in ECT-related anxiety. A better understanding of ECT-related anxiety trajectories can help in designing anxiety-reducing interventions.

Long-term neurocognitive functioning after electroconvulsive therapy in patients with late-life depression.

OBJECTIVE: There is ongoing concern about the possible negative impact of ECT on neurocognitive functioning in older patients. In this study, we aimed to characterize the long-term cognitive effects of ECT in patients with late-life depression, using an extensive neuropsychological battery. METHODS: A total of 110 patients aged 55 years and older with unipolar depression, referred for ECT were included. The neuropsychological test battery was assessed prior to ECT and 6 months after the last ECT session. RESULTS: There were no statistically significant group-level changes from baseline to 6 months post-ECT in any of the neuropsychological measurements. Individual differences in cognitive performance were detected using the Reliable Change Index. CONCLUSION: Patients with late-life depression do not show deleterious cognitive effects 6 months following an ECT index course, although there are considerable differences at an individual level. Clinicians should not hesitate to prescribe ECT in older patients, as most of these patients will tolerate the treatment course and a small group will even experience a cognitive enhancement. However, clinicians should be aware that a small group of patients can experience cognitive side-effects. Further study is needed to predict which patients have a higher risk of developing cognitive side-effects.

[ResPECT - a decade of Flemish-Dutch ECT research]. / ResPECT ­ een decennium Vlaams-Nederlands onderzoek naar elektroconvulsietherapie.

BACKGROUND: There is increasing clinical and scientific interest in electroconvulsive therapy (ECT). AIM: To provide an overview of the main research findings of the Flemish-Dutch research consortium ResPECT. METHOD: We report on our review of the relevant literature. RESULTS: Our studies confirm that ECT is one of the most efficient treatments for depression in later life and for depression with psychotic features. Older people with age-related brain pathology can respond well to ECT. It is still preferable to apply a standard pulse-width because this increases the efficacy of the treatment and minimises the cognitive impact. Even vulnerable older people can react favourably to ECT. CONCLUSION: Recent findings of the ResPECT consortium are providing new insights that are applicable in daily clinical practice. Research into mechanisms of action can also increase our understanding of the pathophysiology of severe depression.

[Doctor, will I get my memory back? Electroconvulsive therapy and cognitive side-effects in daily practice]. / Dokter, komt mijn geheugen terug? Elektroconvulsietherapie en cognitieve bijwerkingen in de praktijk.

BACKGROUND: Patients undergoing or about to undergo electroconvulsive therapy (ECT) are often afraid they will experience negative cognitive side-effects. AIM: To answer questions that patients and referring clinicians often ask about cognitive problems that can result from ECT. METHOD: To discuss, on the basis of clinical perception and literature, the cognitive problems resulting from ECT. RESULTS: The cognitive problems resulting from ect are threefold: short-term postictal confusion (immediately after the treatment), anterograde amnesia and retrograde amnesia. A patient affected by anterograde amnesia, is temporarily less able to remember what he or she has experienced over a period of three months after treatment. The brain of a patient with retrograde amnesia is unable to retrieve or remember information or procedures 'saved' before the treatment took place. More specifically the patient with retrograde amnesia has three main types of problems: semantic memory problems (relating to facts), episodic memory problems (no longer able to retrieve memories concerning non-personal events), and procedural memory problems (no longer able to operate various devices). It is difficult to predict which patients will experience cognitive problems as a result from ect and to what extent. However, the problems are not intensified by maintenance treatment. Factual and autobiographical memory problems following ect-induced retrograde amnesia seems to have a more permanent character. According to the Dutch guidelines for ECT, cognitive side-effects need to be monitored. If patients are monitored before and after ect, they can be given a more targeted psycho-education and eventually a more targeted training course. CONCLUSION: We conclude that in clinical practice increasing attention is being given to ECT-related cognitive side-effects. Clearly, however, more consideration needs to be given to inter-individual variability. Cognitive monitoring is advisable because the course of the side-effects of ect must be followed and evaluated.