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

This study has been completed.
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01842009
First received: April 18, 2013
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Fibromyalgia
Chronic Pain
Device: High Definition transcranial Direct Current Stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 20
Actual Study Start Date: March 2013
Study Completion Date: June 7, 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active anodal HD-tDCS
Subjects will undergo 20 minutes active HD-tDCS.
Device: High Definition transcranial Direct Current Stimulation
Other Name: 4X1 low-intensity direct current stimulator

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842009

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
ElMindA Ltd
Investigators
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01842009     History of Changes
Other Study ID Numbers: 2013P000384
Study First Received: April 18, 2013
Last Updated: March 17, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spaulding Rehabilitation Hospital:
transcranial stimulation
direct current

Additional relevant MeSH terms:
Chronic Pain
Fibromyalgia
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 24, 2017