TMS + D-Cycloserine for Fibromyalgia
Trial Summary
What is the purpose of this trial?
This trial tests a new treatment for fibromyalgia using magnetic brain stimulation combined with a medication. It aims to help adults with fibromyalgia who haven't found relief from other treatments. The treatment works by using magnets to change brain activity and the medication to boost this effect.
Will I have to stop taking my current medications?
The trial requires that you have not changed your dose or started any new psychotropic medications in the 4 weeks before joining. Additionally, you cannot be taking benzodiazepines, cyclopyrrolones, gabapentin/pregabalin, anticonvulsants, ethionamide, or isoniazid.
What data supports the effectiveness of the treatment iTBS-DCS for fibromyalgia?
Research shows that transcranial magnetic stimulation (TMS) can reduce pain in fibromyalgia patients, with one study finding a 29% reduction in pain after TMS sessions. Additionally, intermittent theta-burst stimulation (iTBS), a form of TMS, has been effective in reducing neuropathic pain, suggesting potential benefits for fibromyalgia as well.12345
Is the combination of TMS and D-Cycloserine safe for humans?
How is the iTBS-DCS treatment different from other fibromyalgia treatments?
The iTBS-DCS treatment combines intermittent theta-burst stimulation (a type of brain stimulation) with D-Cycloserine (a medication that can enhance brain plasticity), offering a novel approach that may improve pain and quality of life in fibromyalgia patients by potentially enhancing the effects of brain stimulation.357810
Research Team
Alexander McGirr, MD
Principal Investigator
University of Calgary
Eligibility Criteria
Adults aged 18-65 with fibromyalgia, who haven't responded to certain medications or therapy, can join this trial. They must score ≥41 on the FIQR, have normal recent blood work, and not be on new psychotropic meds for the last month. Pregnant individuals or those at significant risk of harm are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 weeks of rTMS treatment with either D-Cycloserine or placebo, with daily capsule ingestion and 20 TMS sessions.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of clinical symptoms, cognitive function, and imaging.
Extension
Optional continuation of monitoring and assessment to compare treatment effects with healthy controls.
Treatment Details
Interventions
- iTBS-DCS
iTBS-DCS is already approved in United States, Canada for the following indications:
- Urinary tract infections
- Urinary tract infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor