Using brain stimulation and medication to treat fibromyalgia
A Randomized Controlled Trial of Adjunctive D-Cycloserine to Intermittent Theta-burst Stimulation Transcranial Magnetic Stimulation in Fibromyalgia
This study is testing if a combination of brain stimulation and medication can help adults with fibromyalgia feel less pain and improve their mood and quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05395494 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a combination of repetitive Transcranial Magnetic Stimulation (rTMS) and D-Cycloserine in treating fibromyalgia symptoms in adults aged 18-65. Participants will be randomized to receive either the active treatment or a placebo, with assessments of pain, mood, anxiety, and quality of life conducted at multiple time points. The study aims to evaluate both clinical outcomes and neuroimaging changes associated with the treatment. Additionally, participants will undergo various tests to ensure eligibility and monitor health throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of fibromyalgia who have not found relief from standard treatments.
Not a fit: Patients with a history of substance use disorder or those allergic to D-Cycloserine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from fibromyalgia who have not responded to conventional therapies.
How similar studies have performed: Previous studies have shown promise with non-invasive brain stimulation techniques in fibromyalgia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females aged 18 to 65 years 2. are competent to consent to treatment 3. have a diagnosis of fibromyalgia as per the American College of Rheumatology 2016 fibromyalgia criteria. 4. have failed to achieve a clinical response to an adequate trial of a serotonin reuptake inhibitor, a norepinephrine reuptake inhibitor, cognitive behavioral therapy or have been unable to tolerate these medications/access psychotherapy. 5. have a score ≥ 41 on the FIQR. 6. have had no change in dose, or initiation of any psychotropic medication in the 4 weeks prior to randomization 7. are able to adhere to the treatment schedule 8. pass the TMS adult safety screening (TASS) and MRI screening questionnaire 9. have had blood work within the last month (complete blood count, electrolytes, BUN, creatinine, eGFR, AST, ALT and GGT) within the reference range. Exclusion Criteria: 1. Allergy to cycloserine or any excipients. 2. have an alcohol or substance use disorder within the last 3 months 3. have suicidal ideation (score of 4 ≥ on item 10 of MADRS or positive response to item 4 on the CSSRS-screen) 4. are at a significant risk of harm to themselves or others 5. current symptoms of psychosis 6. history of psychosis 7. are currently pregnant, breast feeding or plan to become pregnant. Health Canada requires that women of reproductive potential utilize either highly effective birth control or double barrier method of contraception. Abstinence is only acceptable when it is the usual and preferred lifestyle of the participant. 8. history of non-response to rTMS treatment. 9. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of epilepsy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes 10. have concomitant major unstable medical illness, cardiac pacemaker, or implanted medication pump 11. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed 12. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study 13. are currently (or in the last 4 weeks) not taking any benzodiazepine, cyclopyrrolone, gabapentin/pregabalin or anticonvulsant due to the potential to limit iTBS efficacy 14. are being currently treated with ethionamide or isoniazid
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Alexander McGirr, MD, PhD — University of Calgary
- Study coordinator: Alexander McGirr, MD, PhD
- Email: alexander.mcgirr@ucalgary.ca
- Phone: 403 210 6410
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.