Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
CompletedNot applicableNCT01842009
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
- Conditions
- Interventions
- Device: High Definition transcranial Direct Current Stimulation
- Sponsor
- Spaulding Rehabilitation Hospital
- Collaborators
- ElMindA Ltd
- Start date
- 2013-03
- Primary completion
- 2014-07
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01842009