Major Depressive Disorder
Conditions
Keywords
transcranial magnetic stimulation, computerized cognitive training
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.
Interventions
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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed