- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876758
Cognitive Training for Memory Deficits Associated With Electroconvulsive Therapy
July 13, 2017 updated by: New York State Psychiatric Institute
Although electroconvulsive therapy (ECT) remains the most effective treatment for people with severe depression, patients may experience a significant degree of persistent and/or permanent memory problems following ECT.
Many patients report the memory problems are the most disturbing and serious side effect of ECT, and that such effects impact their quality of life following treatment and their willingness to consent to further ECT needed to complete a treatment course or to maintain remission.
New developments in the field of cognitive remediation have demonstrated the benefits of cognitive training to improve memory performance in various conditions, such as epilepsy.
However, these strategies have never been applied to help patients regain memory after ECT.
The investigators have designed and piloted a novel cognitive program specifically targeted to the cognitive effects of ECT, based upon a program tailored to people with seizure disorders, a group with memory problems very similar to people who undergo ECT.
This Memory Training for ECT (Mem-ECT) is designed to help cognitive functions that may be compromised following ECT remain relatively preserved.
In addition, the intervention attempts to help ECT patients quickly regain their general memory skills immediately following ECT.
Recent results from our preliminary group of patients who underwent ECT and memory training at New York Presbyterian shows no overall decline in memory function following ECT.
On the basis of these promising findings, the investigators propose a more rigorous and larger study to confirm whether this novel memory training program can help alleviate memory problems associated with ECT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators propose to enroll 60 patients scheduled to undergo ECT over the course of 3 years.
They will be randomly assigned to one of three research conditions (a) participants in Mem-ECT condition will receive memory training before and after their ECT course, (b) participants in the active control condition will work on commercially available puzzle games at the same times prior and after ECT to determine if the developed memory training program is more effective than mere mental stimulation, (c) participants in the "treatment as usual" will not work on the memory training or the puzzle games but just undergo the study evaluations.
Participants will be evaluated a few days before ECT, within 2 weeks following ECT, and once again 2 months later.
The evaluation will consist of interviews, mental skill testing, and measuring brain waves using an electroencephalograph (EEG) before ECT and 2 months after ECT (no EEG right after ECT).
It is our hope that developing a safe and effective strategy to minimize the adverse memory side effects of ECT will make ECT a better and more easily tolerated treatment for patients with severe depression who need this therapeutic option.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Major Depressive Disorder
- Inpatient at NYSPI or Presbyterian Hospital
- Scheduled to undergo right-unilateral electroconvulsive therapy in the next two weeks
- We do not require participants to be psychiatrically stable in terms of their symptoms. They only need to demonstrate capacity to consent and be willing to sit through 3 training sessions prior to ECT and 5 sessions post ECT
Exclusion Criteria:
- Significant auditory/visual impairment that would interfere with study procedures
- Lack of aptitude in English that may interfere with the administration of the tests
- Changes in the type of antidepressant during the course of ECT or 2 weeks post ECT
- Chart diagnosis of any other medical or neuropsychiatric illnesses known to impair brain function (e.g. mental retardation, traumatic brain injury, schizophrenia)
- History of ECT in past 2 months
- Mental status examination score below 40/57
- Current substance abuse (e.g. marijuana or crack), excluding nicotine and caffeine.
- Too agitated to sit through the required tests or training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Intervention: Memory Training
Memory training before and after ECT
|
Paper-and-pencil and computerized exercises pre- and post-ECT which may be helpful in recovering episodic memories and allow for the retention of learned strategies
|
Active Comparator: Comparable general mental stimulation
Puzzle games before and after ECT
|
Active control will work on commercially available puzzle games at the same time prior and after ECT to determine if the developed memory training program is more effective than mere mental stimulation.
|
No Intervention: Treatment as Usual
No memory training or puzzle games, just the study evaluations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)
Time Frame: 2 months after the last ECT session
|
2 months after the last ECT session
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Goldberg Remote Memory Questionnaire
Time Frame: 2 months after the last ECT session
|
2 months after the last ECT session
|
Hamilton Rating Scale for Depression-24 item
Time Frame: 2 months after the last ECT session
|
2 months after the last ECT session
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Mini-Mental State examination
Time Frame: 2 months after the last ECT session
|
2 months after the last ECT session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joan Prudic, MD, New York State Psychiatric Institute
- Principal Investigator: Jimmy Choi, PsyD, New York State Psychiatric Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
June 3, 2013
First Submitted That Met QC Criteria
June 10, 2013
First Posted (Estimate)
June 13, 2013
Study Record Updates
Last Update Posted (Actual)
July 14, 2017
Last Update Submitted That Met QC Criteria
July 13, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #6599
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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