Clinical trial NCT04317495: Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder
Official title: Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: transcranial magnetic stimulation
computerized cognitive training
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Feasibility assessed by percentage of CCT sessions completed during rTMS
timeFrame: approximately 30 days (usually 20-30 sessions)
Secondary outcomes:
measure: Time on task during treatment
timeFrame: For each day: 45 min; for entire treatment: approx 30 days
measure: Acceptability of CCT
timeFrame: through study completion date, up to 2 years
measure: Cognitive Control Performance change over course of treatment
timeFrame: Approximately 30 days (usually 20-30 sessions)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephan Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: