Examining brain stimulation effects on pain in depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on chronic pain symptoms in individuals with Major Depressive Disorder (MDD). A total of 54 participants will undergo 30 treatments of rTMS, alongside various assessments including surveys, blood draws, MRIs, and electroencephalograms. The study aims to understand the neuro-immune interactions that contribute to both chronic pain and depression, particularly in treatment-resistant cases. All participants will receive active treatment, with no control group involved.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* Are mentally or legally incapacitated, unable to give informed consent.
* Are pregnant.
* Have an active suicidal intent or plan.
* Have had prior Transcranial Magnetic Stimulation treatment.
* Have an infection or poor skin condition over the scalp where the device will be positioned.
* Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure.
* Psychotic depression or other acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
* Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
* Presence of an implanted metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI)

Where it's running

• UCLA Semel Institute
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Doan Ngo, BS
• Email: thucdoanngo@mednet.ucla.edu
• Phone: 310-825-7797

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.