Examining brain stimulation effects on pain in depression
Multi-target Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Major Depressive Disorder (MDD) and Comorbid Pain
This study is testing whether a type of brain stimulation can help people with depression who also have chronic pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04556890 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18-75 with moderate Major Depressive Disorder and chronic pain who have not responded to multiple antidepressant treatments.
Not a fit: Patients who do not have a confirmed diagnosis of Major Depressive Disorder or chronic pain, or who have not failed multiple treatment trials, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach for alleviating chronic pain in patients suffering from Major Depressive Disorder.
How similar studies have performed: Other studies have shown promising results with rTMS for depression, but this specific approach targeting chronic pain in MDD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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. 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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.