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

Mass General Brigham

Status

Completed

Conditions

Fibromyalgia

Chronic Pain

Treatments

Device: High Definition transcranial Direct Current Stimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01842009

2013P000384

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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