The Effect of Transcranial Direct Current Stimulation on Cognitive Side Effects of Electroconvulsive Therapy
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|ClinicalTrials.gov Identifier: NCT02897843|
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : May 22, 2019
Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction continues to be a frequent adverse effect. Declarative memory and less so selective memory are often impaired after an ECT course. Immediate memory, however, is broadly preserved. It is hypothesized that memory impairments are due to ECT induced disruptions on long term potentiation as well as in cerebral flux and glutamatergic and cholinergic systems. Different pharmacological agents for the treatment of ECT induced cognitive dysfunction have been tried. Agents such as opioids, vasopressin, neuropeptides, cholinergic agents, thyroid hormone, and stimulants have been used with equivocal results, and no controlled studies showed clear efficacy.
Transcranial direct current stimulation (tDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. Electrical currents are applied constantly at low intensities (1-2 mA) over a long period, usually in minutes (5-30 minutes), to achieve changes in cortical excitability by influencing spontaneous neural activity. There are two types of stimulation with tDCS: anodal and cathodal stimulation. Anodal stimulation acts to excite neuronal activity while cathodal stimulation inhibits or reduces neuronal activity. Several studies demonstrated moderate to strong effect sizes of tDCS in various neurocognitive and neuropsychiatric settings. Majority of studies show positive effects of tDCS on cognitive functioning among healthy volunteers and subjects with neurological or psychiatric conditions. Beneficial effects of online stimulation applied over the left dorsolateral prefrontal cortex have been reported for working memory, attention and information processing in depressed patients. To the investigators' knowledge no studies have evaluated the potential efficacy of tDCS for the prevention of ECT induced cognitive adverse effects.
In the current study, the investigators propose a double blind, randomized controlled trial to test the use of tDCS as a strategy to prevent or mitigate the memory impairments frequently associated with an ECT course.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Device: transcranial magnetic stimulation Device: sham tDCS||Not Applicable|
This is a prospective, random assignment, double blind, parallel group study with an adaptive design comparing the efficacy of tDCS performed during the course of ECT to that of sham tDCS in patients with a major depressive episode being treated with ECT. The investigators intend to recruit patients who are scheduled to receive an acute course of ECT. Patients who are able and willing to provide written informed consent, and who meet study criteria when screened, will be randomly assigned on a 1:1 ratio to receive a course of real tDCS or sham tDCS. Subjects will receive a standard acute course of bifrontal ECT (3X/week) and depressive symptomatology will be monitored with the Hamilton Rating Scale for Depression (HRSD-24) before each treatment.
The primary outcome will be change in cognition from baseline to end of study. The investigators will monitor cognitive changes before and after each ECT treatment, at the end of the treatment course and two months after the last treatment.
Secondary outcome will be the number of treatments needed to achieve remission. Remission is defined as two consecutive Hamilton Rating Scale for Depression (HRSD) scores <= 10, and HRSD total score does not change > 3 points or remains < 6 at the last two consecutive treatments. In addition, the investigators will collect data on other treatment parameters such as seizure duration, electroencephalogram (EEG) morphology as well as hemodynamic changes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Transcranial Direct Current Stimulation on Cognitive Side Effects of Electroconvulsive Therapy|
|Actual Study Start Date :||February 16, 2017|
|Actual Primary Completion Date :||October 11, 2018|
|Actual Study Completion Date :||April 19, 2019|
Sham Comparator: sham tDCS
Sham tDCS sessions will last 20 minutes, but a real stimulus of 2 milliamps (mA) will be applied only during the first minute
Device: sham tDCS
20 minute tDCS sessions
Device: transcranial magnetic stimulation
tDCS stimulation will involve ten 20 minute stimulations daily, characterized by 2 milliamps (mA) anode over the left dorsolateral prefrontal cortex (DLPFC), with the cathode placed over the right suborbital region.
- Change in memory function [ Time Frame: up to three months ]Change in memory function will be determined by a factor analysis of all memory tests
- Number of ECT treatments needed to achieve remission [ Time Frame: up to three weeks ]Remission is defined as two consecutive Hamilton Rating Scale for Depression (HRSD) scores <= 10, and HRSD total score does not change > 3 points or remains < 6 at the last two consecutive ECT treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897843
|United States, New York|
|The Zucker Hillside Hospital|
|Glen Oaks, New York, United States, 11004|
|Principal Investigator:||Raphael Braga, MD||Northwell Health|