Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
NCT ID: NCT01842009
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2013-03-31
2016-06-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
NCT01402960
Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury
NCT01599767
Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia
NCT01598181
Montage of HTDCS in Psycho-cognitive Functions in FM
NCT04890964
Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain
NCT01849796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active anodal HD-tDCS
Subjects will undergo 20 minutes active HD-tDCS.
High Definition transcranial Direct Current Stimulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High Definition transcranial Direct Current Stimulation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ElMindA Ltd
INDUSTRY
Spaulding Rehabilitation Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Felipe Fregni
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Felipe Fregni, MD PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Castillo-Saavedra L, Gebodh N, Bikson M, Diaz-Cruz C, Brandao R, Coutinho L, Truong D, Datta A, Shani-Hershkovich R, Weiss M, Laufer I, Reches A, Peremen Z, Geva A, Parra LC, Fregni F. Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization. J Pain. 2016 Jan;17(1):14-26. doi: 10.1016/j.jpain.2015.09.009. Epub 2015 Oct 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013P000384
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.