Status:
COMPLETED
Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
ElMindA Ltd
Conditions:
Fibromyalgia
Chronic Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01842009
Start Date
March 1 2013
End Date
June 7 2016
Last Update
April 24 2020
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129