Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

Study Overview
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Brief Summary
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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

Detailed Description
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This project will also have a registry for participants that are approached to be in the clinical trial with the CCT but don't wish to be enrolled. Although the registry will be available for these participants, the information entered into this ClinicalTrials.gov registration will reflect the clinical trial portion of this project.

Official Title
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Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Computerized Cognitive Training (CCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized Cognitive Training (CCT)<br>The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment). | Other: Computerized Cognitive Training (CCT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility assessed by percentage of CCT sessions completed during rTMS | Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100 | approximately 30 days (usually 20-30 sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on task during treatment | Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions | For each day: 45 min; for entire treatment: approx 30 days | 
| Acceptability of CCT | Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100 | through study completion date, up to 2 years | 
| Cognitive Control Performance change over course of treatment | Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions. | Approximately 30 days (usually 20-30 sessions) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial magnetic stimulation, computerized cognitive training