Theta Burst Stimulation in fibromyalgia
A double-blind randomized sham-controlled trial to evaluate the effect of prefrontal Theta Burst Stimulation on severity and impact of pain in patients with fibromyalgia
Dr Bernadette Fitzgibbon
52 participants
Jun 15, 2017
Interventional
Conditions
Summary
The proposed study aims to conduct a double-blind, randomized, sham-controlled proof of principle trial to establish the efficacy of Theta Burst Stimulation (TBS) treatment in fibromyalgia. Fibromyalgia and related disorders present a substantial health problem, with current treatments limited in their efficacy and associated with a number of side effects. This study will explore for the first time in fibromyalgia a novel non-pharmaceutical intervention, TBS; a non-invasive brain stimulation method. TBS is a powerful new alternative to standard non-invasive brain stimulation methods as it can be applied in a much more time efficient manner and may result in greater clinical benefit. If successful, the application of this method for fibromyalgia may be applicable to related disorders such as Chronic Fatigue Syndrome. This is a randomised sham-controlled trial study, in which 52 participants with a diagnosis of fibromyalgia will be recruited. Participants will be randomised into one of two conditions- (1) Active TBS condition and (2) Sham (or ‘placebo’) TBS condition. Participants will have two weeks of twice daily stimulation followed by a tapered two week dose of twice daily treatments on Monday, Wednesday and Friday only. Participants will be asked to a number of self-report questionnaires at baseline, at the end of each treatment week (weeks 1-4) and at the 1 month follow up appointment, as well as will undergo the collection of neurobiological data (TMS-EEG) at baseline, end of week 4 and follow-up.
Eligibility
Inclusion Criteria3
- have a current diagnosis of fibromyalgia
- aged between 18 and 75 years
- have had no increase or initiation of new medication therapy in the four weeks prior to study screen
Exclusion Criteria3
- Patients who have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- The presence of metal anywhere in the head, except the mouth, which may interfere with the magnetic field
- Have a current DSM-V diagnosis of Substance Abuse or Dependence disorder, or another psychiatric condition. This excludes depression, PTSD or anxiety unless they are the primary disorder (i.e. fibromyalgia is not the primary disorder).
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Interventions
Theta Burst Stimulation (TBS). Participants will undergo 32 treatment sessions across 4 weeks administered by a research nurse. Each TBS procedure will take approximately 3 minutes and you will complete two TBS treatments at each visit (total of 6 minutes of TBS treatment per visit, 15 minutes between each treatment). During the initial two weeks of treatment, participants will attend daily (Monday-Friday) treatment. During the final two weeks of treatment, participants will attend treatment on Mondays, Wednesdays and Fridays only. TBS will be administered with a NeuroSoft-MS/D or Magventure Magpro magnetic stimulator using a figure-of-8 coil, dependent on patient scheduling. Prior to the commencement of rTMS treatment, single pulse TMS will be used to measure the resting motor thresholds (RMT) in all subjects using standard methods. The RMT is used to determine the intensity of the rTMS treatment and is a means of tailoring the stimulus intensity for each participant. Participants will be randomly allocated to receive either active or sham TBS via a computer generated sequence by a study investigator who is not involved in treatment or assessment. In active TBS treatment, participants will receive 3-pulse 50Hz bursts applied at 5Hz. Stimulation intensity will be set at up to 120% RMT and will be applied to the left dorsolateral prefrontal cortex. To assess fidelity of blinding we will be conducting blinding questionnaires with participants at the end of their treatment..The above protocol is in compliance with current published TBS safety guidelines.
Locations(1)
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ACTRN12617000487314