Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes
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|ClinicalTrials.gov Identifier: NCT03289923|
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : August 31, 2020
Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective.
To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression.
Adults ages 18-65 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks.
Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests.
Phase 1 is 1-4 visits in 1 week. Participants will have:
- Brain MRI. Participants will lie on a table in a scanner.
- Questions about their medical history and psychology symptoms
- Tests of mood and thinking
Tests of brain activity. Participants may do tasks during these tests:
- A cone with magnetic detectors is put on the head.
- A cap with electrodes is put on the scalp.
- TMS. A brief electrical current passes through a wire coil on the scalp.
- A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock.
Phase 2 is about 6 to 7 weeks.
- There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks.
- Participants will receive rTMS and another therapy by computer.
- For rTMS, repeated pulses will pass through the coil.
This is followed by up to 3 additional visits, when:
- Participants will repeat Phase 1 tests
- Participants will rate their depression symptoms.
Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Other: sham TMS Device: TMS Behavioral: Self-System Therapy Behavioral: Mindfulness exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||March 1, 2029|
|Estimated Study Completion Date :||March 1, 2029|
Sham Comparator: Sham TMS + active psychological placebo
Other: sham TMS
Inactive Transcranial Magnetic Stimulation
Behavioral: Mindfulness exercises
Computer interfaced brief mindfulness exercises facilitated by the therapist
FDA label standard Tx
Behavioral: Self-System Therapy
Self-System Therapy (SST)
- Change in magnitude of Bold signal [ Time Frame: 6 weeks after initiating intervention ]change in magnitude of BOLD signal with fMRI bold signal from DLPFC
- Electrophysiological changes using MEG and EEG measures [ Time Frame: 6 weeks after initiating intervention ]Recordings of brain activity
- Clinical Rating Scales: BSL, C-SSRS, CTQ, HAM-A, NIH-BFI, PANAS, RBANS, RRS, SHAPS, and TLEQ [ Time Frame: Variable: some 6 weeks after initiating intervention; others weekly ]Clinical symptom scales from which we derive scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289923
|Contact: Cristina Abboud||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Sarah H Lisanby, M.D.||National Institute of Mental Health (NIMH)|