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

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ClinicalTrials.gov Identifier: NCT01842009
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE April 18, 2013
First Posted Date  ICMJE April 29, 2013
Last Update Posted Date July 13, 2017
Actual Study Start Date  ICMJE March 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS) [ Time Frame: approximately 4.5 months ]
Investigate the mean number of sessions (up to 26) needed to achieve clinical response associated with the use of HD-tDCS over the primary motor cortex (M1), with response defined at a 50% decrease in baseline Visual Analogue Scale (VAS) for pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01842009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
  • Number of subjects who achieve clinical response [ Time Frame: Approximately 4.5 months ]
    We will count the number of subjects who achieve clinical response (as defined in Aim 1 as a 50% reduction in baseline VAS) for the duration of the trial.
  • Measurement of sensory and auditory evoked potentials [ Time Frame: Approximately 4.5 months ]
    We will measure brain pain response using electroencephalography (EEG) to measure somatosensory Event Related Potentials (ERPs) with a heat pain threshold device. We will also measure auditory ERPs. We will investigate the relationship between these ERP measurements and overall clinical response of patients (as outlined in Aim 1 and Aim 2)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Official Title  ICMJE Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fibromyalgia
  • Chronic Pain
Intervention  ICMJE Device: High Definition transcranial Direct Current Stimulation
Other Name: 4X1 low-intensity direct current stimulator
Study Arms Experimental: Active anodal HD-tDCS
Subjects will undergo 20 minutes active HD-tDCS.
Intervention: Device: High Definition transcranial Direct Current Stimulation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
15
Actual Study Completion Date June 7, 2016
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01842009
Other Study ID Numbers  ICMJE 2013P000384
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Felipe Fregni, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE ElMindA Ltd
Investigators  ICMJE
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
PRS Account Spaulding Rehabilitation Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP