Status:
TERMINATED
iTBS-DCS in Fibromyalgia
Lead Sponsor:
University of Calgary
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Background \& Rationale: Fibromyalgia is characterized by widespread pain, fatigue, mood and anxiety as well as cognitive complaints. For an unacceptable proportion of patients, depressive symptoms re...
Detailed Description
Methods: 90participants (males and females aged aged 18-65, with a diagnosis of fibromyalgia of at least moderate moderate impact as defined by a FIQR score of ≥39, stable psychotropic medication for ...
Eligibility Criteria
Inclusion
- Males and females aged 18 to 65 years
- are competent to consent to treatment
- have a diagnosis of fibromyalgia as per the American College of Rheumatology 2016 fibromyalgia criteria.
- 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.
- have a score ≥ 41 on the FIQR.
- have had no change in dose, or initiation of any psychotropic medication in the 4 weeks prior to randomization
- are able to adhere to the treatment schedule
- pass the TMS adult safety screening (TASS) and MRI screening questionnaire
- have had blood work within the last month (complete blood count, electrolytes, BUN, creatinine, eGFR, AST, ALT and GGT) within the reference range.
Exclusion
- Allergy to cycloserine or any excipients.
- have an alcohol or substance use disorder within the last 3 months
- have suicidal ideation (score of 4 ≥ on item 10 of MADRS or positive response to item 4 on the CSSRS-screen)
- are at a significant risk of harm to themselves or others
- current symptoms of psychosis
- history of psychosis
- 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.
- history of non-response to rTMS treatment.
- 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
- have concomitant major unstable medical illness, cardiac pacemaker, or implanted medication pump
- 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
- 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
- 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
- are being currently treated with ethionamide or isoniazid
Key Trial Info
Start Date :
August 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT05395494
Start Date
August 29 2022
End Date
July 31 2025
Last Update
August 17 2025
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4