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TMS + D-Cycloserine for Fibromyalgia

Phase 2
Waitlist Available
Led By Alexander McGirr, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females aged 18 to 65 years
are competent to consent to treatment
Must not have
Current symptoms of psychosis
History of non-response to rTMS treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
The trial is testing if a brain stimulation technique called iTBS combined with D-Cycloserine (a medication) is more effective in treating fibromyalgia symptoms than iTBS alone. Participants will either receive D-Cycloserine or a placebo alongside TMS treatments.
What are the potential side effects?
While iTBS generally has a good safety profile, potential side effects may include discomfort at the stimulation site, headache, lightheadedness, and rare seizures. D-Cycloserine could cause allergic reactions and mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I understand and can agree to my treatment plan.
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I have been diagnosed with fibromyalgia according to the 2016 criteria.
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I have been diagnosed with fibromyalgia according to the 2016 criteria.
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I haven't improved with certain depression treatments or couldn't handle them.
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I have been diagnosed with fibromyalgia according to the 2016 criteria.
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I didn't improve with specific depression treatments or couldn't handle them.
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I am between 18 and 65 years old.
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I have been diagnosed with fibromyalgia according to the 2016 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing symptoms of psychosis.
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I did not respond to previous rTMS treatment.
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I do not have major brain or nerve conditions like severe head injury, epilepsy, or Parkinson's.
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I do not have a severe illness, pacemaker, or medication pump.
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I am currently taking ethionamide or isoniazid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differential change in the will be mediated by D-Cycloserine plasma level
Differential change in the will be mediated by fidelity to the protocol
Revised Fibromyalgia Impact Questionnaire (FIQR)
+1 more
Secondary study objectives
Change in Anxiety as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29)
Change in Central Sensitization Pain as measured by the The Central Sensitization Inventory (CSI)
Change in Cognitive Function - THINC-integrated tool (THINC-it)- Choice Reaction Time
+42 more
Other study objectives
Incidence of Treatment-Emergent Adverse Events
Side Effects

Side effects data

From 2012 Phase 4 trial • 169 Patients • NCT00633984
8%
General
7%
Other
7%
Neurological
6%
GI
3%
Cognitive/Emotional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cognitive Behavioral Therapy + DCS
Cognitive Behavioral Therapy + Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: D-CycloserineExperimental Treatment2 Interventions
Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine daily (Monday-Friday) during 4 weeks of rTMS treatment (20 sessions) 60-120 minutes prior to rTMS treatment.
Group II: PlaceboPlacebo Group2 Interventions
Participants will orally ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) 60 - 120 minutes prior to rTMS treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-Cycloserine
2011
Completed Phase 4
~1850

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for fibromyalgia include medications like tricyclic antidepressants (e.g., amitriptyline), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), and muscle relaxants (e.g., cyclobenzaprine). These medications work by altering neurotransmitter levels to reduce pain perception, improve sleep, and alleviate mood disturbances. Transcranial Magnetic Stimulation (TMS) targets brain regions involved in pain and mood regulation, using magnetic fields to modulate neuronal activity. D-Cycloserine, when used adjunctively with TMS, enhances these neurophysiological effects, potentially leading to greater improvements in pain, mood, and cognitive function. This is particularly important for fibromyalgia patients, as it offers a non-invasive treatment option that addresses multiple symptom domains, providing a comprehensive approach to managing this complex condition.
Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial.Fibromyalgia Pain and Depression: An Update on the Role of Repetitive Transcranial Magnetic Stimulation.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
806 Previous Clinical Trials
883,982 Total Patients Enrolled
Alexander McGirr, MD, PhDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
101 Total Patients Enrolled

Media Library

iTBS-DCS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05395494 — Phase 2
Fibromyalgia Research Study Groups: D-Cycloserine, Placebo
Fibromyalgia Clinical Trial 2023: iTBS-DCS Highlights & Side Effects. Trial Name: NCT05395494 — Phase 2
iTBS-DCS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395494 — Phase 2
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05395494 — Phase 2
~44 spots leftby Dec 2026