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



Status:Active, not recruiting
Conditions:Chronic Pain, Chronic Pain, Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:July 2013

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts 02129
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mi
from
Charlestown, MA
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