Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

University of Michigan

Status: Terminated

Conditions: Major Depressive Disorder

Treatments: Other: Computerized Cognitive Training (CCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04317495

HUM00161598

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Computerized Cognitive Training (CCT)

Experimental group

Description:

The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).

Treatment:

Other: Computerized Cognitive Training (CCT)