Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
NCT01842009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2020-04-24
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 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.
Conditions
- Fibromyalgia
- Chronic Pain
Interventions
- DEVICE
-
High Definition transcranial Direct Current Stimulation
Sponsors & Collaborators
-
ElMindA Ltd
collaborator INDUSTRY -
Spaulding Rehabilitation Hospital
lead OTHER
Principal Investigators
-
Felipe Fregni, MD PhD MPH · Spaulding Rehabilitation Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2014-07-31
- Completion
- 2016-06-07
Countries
- United States
Study Locations
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