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

Completed · Not applicable

Conditions studied: Fibromyalgia, Chronic Pain

In brief

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.

Key facts

Study ID: NCT01842009
Run by: Spaulding Rehabilitation Hospital
People needed: 20
Starts: 2013-03-01
Expected to finish: 2016-06-07
Last updated by the study team: 2020-04-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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