Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
Exploration of Parameters of tDCS in Chronic Pain Patients
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Apr 2011
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2013
CompletedApril 24, 2020
April 1, 2020
10 months
June 29, 2011
April 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain scales
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.
Measured for approximately 5 weeks
Secondary Outcomes (1)
Change in cutaneous hyperalgesia/allodynia
Measured for approximately 5 weeks.
Study Arms (3)
Active Anodal HD-tDCS
EXPERIMENTALSubject will receive one 20-minute session of active anodal HD-tDCS.
Active Cathodal HD-tDCS
EXPERIMENTALSubject will receive one 20-minute session of active cathodal HD-tDCS.
Sham HD-tDCS
SHAM COMPARATORSubject will receive one sham session of HD-tDCS
Interventions
Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA. * For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes. * For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes. * For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)
Eligibility Criteria
You may qualify if:
- Providing informed consent to participate in the study
- 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
You may not qualify if:
- Pregnancy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD, PhD, MPH
Spaulding Rehabilitation Hospital (SRH)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 26, 2011
Study Start
April 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 13, 2013
Last Updated
April 24, 2020
Record last verified: 2020-04