Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

Not Applicable

Terminated

• Conditions: Major Depressive Disorder
• Interventions: Other: Computerized Cognitive Training (CCT)

• Registration Number: NCT04317495
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-27
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Status Verified: 2021-04
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computerized Cognitive Training (CCT)	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).

Primary Outcome Measures

Name	Time	Method
Feasibility assessed by percentage of CCT sessions completed during rTMS	approximately 30 days (usually 20-30 sessions)	Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100

Secondary Outcome Measures

Name	Time	Method
Acceptability of CCT	through study completion date, up to 2 years	Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
Time on task during treatment	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
Cognitive Control Performance change over course of treatment	Approximately 30 days (usually 20-30 sessions)	Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States