What side effects are associated with this type of intervention?

Common treatments for fibromyalgia, such as Transcranial Magnetic Stimulation (TMS) and adjunctive medications like D-Cycloserine, have specific side effects. TMS can cause headache, scalp discomfort, tingling, facial muscle spasms, and lightheadedness, with rare occurrences of seizures. D-Cycloserine, used to enhance the effects of TMS, may cause dizziness, headache, and fatigue. These treatments aim to improve symptoms while maintaining a favorable tolerability profile.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of fibromyalgia, including pregabalin, duloxetine, and milnacipran. These medications primarily target pain and mood symptoms associated with fibromyalgia. While Transcranial Magnetic Stimulation (TMS) has shown promise in treating fibromyalgia by altering neuronal activity, it is not yet FDA-approved specifically for this condition. However, TMS is FDA-approved for major depressive disorder, which shares some symptomatic overlap with fibromyalgia. D-Cycloserine, an adjunctive medication, is being studied to enhance the effects of TMS, but it is not yet approved for fibromyalgia treatment.

What other types of research exist?

Promising novel alternatives for Fibromyalgia treatment in 2024 include noninvasive vagus nerve stimulation (nVNS) and external trigeminal neurostimulation (eTNS). These methods have shown efficacy in other neurological conditions and could offer benefits for Fibromyalgia patients. Additionally, exploring other pharmacological agents that modulate neurotransmitter systems, such as SSRIs or other neuromodulatory drugs, may provide new avenues for treatment.

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TMS + D-Cycloserine for Fibromyalgia

Phase 2

Recruiting

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)

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 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)

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

General

Other

Neurological

Cognitive/Emotional

100%

80%

60%

40%

20%

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

0 / 14Eligibility criteria met

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.