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Clinical Trials/NCT01402960
NCT01402960
Completed
Not Applicable

Exploration of Parameters of tDCS in Chronic Pain Patients

Spaulding Rehabilitation Hospital1 site in 1 country18 target enrollmentApril 2011
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
18
Locations
1
Primary Endpoint
Change in pain scales
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
February 13, 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Felipe Fregni

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

Inclusion Criteria

  • Providing informed consent to participate in the study
  • 18 to 64 years old
  • Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 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.
  • Must have the ability to feel pain as self reported

Exclusion Criteria

  • Contraindications to tDCS
  • metal in the head
  • 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)
  • History of neurological disorders as self reported.
  • History of unexplained fainting spells as self reported,
  • History of head injury resulting in more than a momentary loss of consciousness as self reported
  • History of neurosurgery as self reported

Outcomes

Primary Outcomes

Change in pain scales

Time Frame: Measured for approximately 5 weeks

Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Secondary Outcomes

  • Change in cutaneous hyperalgesia/allodynia(Measured for approximately 5 weeks.)

Study Sites (1)

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