Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04317495
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Other: Computerized Cognitive Training (CCT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
• Actual Study Start Date: Aug 27, 2019
• Actual Primary Completion Date: Apr 1, 2021
• Actual Study Completion Date: Apr 1, 2021

Arms and Interventions

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).

Other: Computerized Cognitive Training (CCT); 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Stephan Taylor, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephan F. Taylor, Professor of Psychiatry, University of Michigan
• ClinicalTrials.gov Identifier: NCT04317495
• Other Study ID Numbers: HUM00161598
• First Posted: Mar 23, 2020
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Stephan F. Taylor, Professor of Psychiatry, University of Michigan: transcranial magnetic stimulation; computerized cognitive training
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Apr 8, 2021