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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
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
Study Summary
This trial is testing whether using a medication called D-cycloserine in conjunction with transcranial magnetic stimulation (TMS) can help improve symptoms in fibromyalgia patients more than TMS alone.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am between 18 and 65 years old.
Select...
I have been diagnosed with fibromyalgia according to the 2016 criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
Incidence of Treatment-Emergent Adverse Events
Side Effects
Side effects data
From 2012 Phase 4 trial • 169 Patients • NCT006339848%
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
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,644 Total Patients Enrolled
Alexander McGirr, MD, PhDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with fibromyalgia according to the 2016 criteria.I am experiencing symptoms of psychosis.I do not have major brain or nerve conditions like severe head injury, epilepsy, or Parkinson's.I haven't started or changed the dose of any mental health medication in the last 4 weeks.Your recent blood tests must show normal levels of various substances like blood cells, electrolytes, and kidney and liver function markers.You have thoughts of hurting yourself or have answered a certain way on a depression screening test.You have a high risk of hurting yourself or someone else.You have a history of experiencing severe mental health issues like losing touch with reality.I am not pregnant, breastfeeding, nor planning to become pregnant and will use effective birth control.I didn't improve with certain depression treatments or couldn't handle them.I am mentally capable of understanding and agreeing to treatment.I didn't improve with specific depression treatments or couldn't handle them.I haven't improved with certain depression treatments or couldn't handle them.I am currently taking ethionamide or isoniazid.You have a metal object in or near your head that can't be safely taken out.I have been in stable psychotherapy for at least 3 months with no expected changes.You are allergic to cycloserine or any of the ingredients in the medication.I am between 18 and 65 years old.You have a Fibromyalgia Impact Questionnaire Revised (FIQR) score of 41 or higher.I did not respond to previous rTMS treatment.I haven't taken any benzodiazepine, cyclopyrrolone, gabapentin/pregabalin, or anticonvulsant in the last 4 weeks.I have been diagnosed with fibromyalgia according to the 2016 criteria.My recent blood tests are all within normal ranges.You have a score of 41 or higher on the FIQR (Fibromyalgia Impact Questionnaire Revised).I do not have a severe illness, pacemaker, or medication pump.Your score on the FIQR questionnaire is 41 or higher.You have had a problem with drinking or using drugs in the last 3 months.I haven't changed or started any mental health medication in the last 4 weeks.I have been diagnosed with fibromyalgia according to the 2016 criteria.I didn't improve with certain depression treatments or couldn't handle them.I have been diagnosed with fibromyalgia according to the 2016 criteria.You have a score of 41 or higher on the FIQR.I am between 18 and 65 years old.I have passed safety screenings for TMS and MRI.I understand and can agree to my treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: D-Cycloserine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05395494 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any adverse effects associated with D-Cycloserine consumption?
"As this is a Phase 2 trial, indicating that there have been some studies conducted to evaluate the safety of D-Cycloserine, our team at Power judged it to be a score of 2. Yet, no clinical data exists in regard to its efficacy yet."
Answered by AI
What aims does this investigation seek to accomplish?
"The primary outcome measure of this clinical trial, to be assessed over an 8-week period, is the Revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes include Change in Cognitive Function - THINC-integrated tool (THINC-it)- Digit Symbol Substitution Test and Change in Social Function as measured by Patient Reported Outcomes Measurement Information System (PROMIS-29), as well as Neuromelanin differences between healthy controls and fibromyalgia patients detected via MRI scans."
Answered by AI
Who fits the criteria for participation in this experiment?
"This study requires 90 individuals suffering from fibromyalgia, ranging between 18 and 65 years of age. Primary criteria for eligibility include: attaining a score ≥41 on the FIQR; having an American College of Rheumatology-approved fibromyalgia diagnosis; being capable to provide informed consent; not receiving any psychotropic medications in the 4 weeks prior to randomization or failing to respond adequately to serotonin reuptake inhibitors, norepinephrine reuptake inhibitors, or cognitive behavioural therapy; passing TMS adult safety screening (TASS) as well as MRI screening questionnaire; possessing reliable blood work results within last month that are"
Answered by AI
How many participants are currently engaged in this medical trial?
"Affirmative. Clinicaltrials.gov reveals that this scientific experiment, which was inaugurated on August 29th 2022, is still actively looking for enrollees. Approximately 90 subjects must be recruited at 1 site in total."
Answered by AI
Does this experiment include participants aged fifty-five and younger?
"Patients that meet the age criteria of 18 years or older but below 65 can participate in this research."
Answered by AI
Are researchers still recruiting participants for this experiment?
"Per the clinicaltrials.gov website, enrollment for this trial is ongoing and was first advertised on August 29th 2022 with recent updates posted as of November 9th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Connecticut
How old are they?
18 - 65
What site did they apply to?
University of Calgary
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
My Fibromyalgia is debilitating. I’ve tried new drugs and exercise and it hasn’t helped.
PatientReceived no prior treatments
I've tried everything for thirty years with only diminishing results . I'm at a point my only option if I don't find an answer is adult foster care home. I'm becoming incapable of working or takin g care of myself. I've become homeless etc.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long would I need to be in Canada for?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- University of Calgary: < 24 hours
Typically responds via
Email
Average response time
- < 2 Days
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