- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04317495
Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder
Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for MDD, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. Given that rTMS is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed.
Therefore, this study will combine computerized cognitive training (CCT) during standard rTMS treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms.
Participants that agree to the study and meet eligibility will receive standard rTMS (generally 25-36 daily treatments) along with CCT (starting on day 5 of treatment until the pre-taper treatment). In addition, to CCT participants will be asked to complete assessments before and after treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of major depressive disorder
- Eligible to receive and recommended for rTMS for depression
- Willingness to complete computerized cognitive training and undergo brain stimulation procedures
- Must be enrolled as a Michigan Medicine patient and currently receiving TMS treatment as part of your clinical care.
Exclusion Criteria:
- History of serious neurological illness or brain injury (e.g., stroke)
- Poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rTMS treatment, but contacts are permissible)
- Diagnosed intellectual disability
- Inability to manipulate a tablet device while seated in the rTMS chair
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerized Cognitive Training (CCT)
The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).
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After having four rTMS sessions without CCT, the patients will perform CCT (starting day 5) during the rTMS session, which typically last from 20-40 minutes.
A course of rTMS therapy includes from 25-36 treatments, given daily, until the last 5-6 treatments, given as a 'taper' over 2 weeks.
CCT will be paired with rTMS up until the taper begins.
In addition, they will have assessments prior to and after the therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility assessed by percentage of CCT sessions completed during rTMS
Time Frame: approximately 30 days (usually 20-30 sessions)
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Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
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approximately 30 days (usually 20-30 sessions)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time on task during treatment
Time Frame: For each day: 45 min; for entire treatment: approx 30 days
|
Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions
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For each day: 45 min; for entire treatment: approx 30 days
|
Acceptability of CCT
Time Frame: through study completion date, up to 2 years
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Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
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through study completion date, up to 2 years
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Cognitive Control Performance change over course of treatment
Time Frame: Approximately 30 days (usually 20-30 sessions)
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Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions.
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Approximately 30 days (usually 20-30 sessions)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00161598
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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