Multi-target Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Major Depressive Disorder (MDD) and Comorbid Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• All Subjects must be between 18-75 years of age

• Language: Participants must speak English fluently, as demonstrated by verbal skills sufficient to answer questions at a level that assures adequate understanding of the study

• All subjects must be right-handed

• Must have confirmed diagnosis of moderate Major Depressive Disorder (single or recurrent episode), minimum score of 17 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). No minimal MDD duration necessary for study participation

• Failure to respond to a minimum of 2 trials of antidepressant medication

• Failure to respond from at least two different agent classes

• Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count)

• Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration\*

• Must have a confirmed FM or ME/CFS diagnoses and moderate pain complaints, minimum score of 15 on the McGill Pain Questionnaire.

• Pain chronicity for at least 3 months prior to study enrollment.

• Subjects are willing and able to adhere to the treatment schedule and required study visits.

Locations
United States
California
UCLA Semel Institute
RECRUITING
Los Angeles
Contact Information
Primary
Doan Ngo, BS
thucdoanngo@mednet.ucla.edu
310-825-7797
Backup
Juliana Corlier, PhD
jcorlier@ucla.edu
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 54
Treatments
Experimental: Active rTMS/Active iTBS DFPLC/Sham Pain M1
Experimental: Active rTMS/Active iTBS
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov