Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia; Chronic Pain
• Interventions: Device: High Definition transcranial Direct Current Stimulation

• Registration Number: NCT01842009
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Primary Completion: 2014-07
• Study Completion: 2016-06-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Providing informed consent to participate in the study
• 18 to 85 years old, both male and female
• Have a diagnosis of Fibromyalgia
• Existing pain for more than 3 months with an average of at least 4 on a 0-10 VAS scale
• Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex and Codeine.

Exclusion Criteria

• Pregnancy
• Contraindications to tDCS: metal in the head or implanted brain medical devices
• History of alcohol or drug abuse within the past 6 months as self-reported
• Use of carbamazepine within the past 6 months as self-reported
• Severe depression (with a score of >30 in the Beck Depression Inventory)
• Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
• History of unexplained fainting spells as self-reported
• Neurosurgery as self-reported

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active anodal HD-tDCS	High Definition transcranial Direct Current Stimulation	Subjects will undergo 20 minutes active HD-tDCS.

Primary Outcome Measures

Name	Time	Method
Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS)	approximately 4.5 months	Investigate the mean number of sessions (up to 26) needed to achieve clinical response associated with the use of HD-tDCS over the primary motor cortex (M1), with response defined at a 50% decrease in baseline Visual Analogue Scale (VAS) for pain.

Secondary Outcome Measures

Name	Time	Method
Number of subjects who achieve clinical response	Approximately 4.5 months	We will count the number of subjects who achieve clinical response (as defined in Aim 1 as a 50% reduction in baseline VAS) for the duration of the trial.
Measurement of sensory and auditory evoked potentials	Approximately 4.5 months	We will measure brain pain response using electroencephalography (EEG) to measure somatosensory Event Related Potentials (ERPs) with a heat pain threshold device. We will also measure auditory ERPs. We will investigate the relationship between these ERP measurements and overall clinical response of patients (as outlined in Aim 1 and Aim 2)

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Charlestown, Massachusetts, United States