Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

NCT ID: NCT04317495

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-27
• Study Completion Date: 2021-04-01

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Computerized Cognitive Training (CCT)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Stephan F. Taylor

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00161598

Identifier Type: -

Identifier Source: org_study_id