Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain - Full Text View

Sponsor:	Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):	Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:	NCT01402960

Purpose

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.

Condition	Intervention	Phase
Chronic Pain	Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Exploration of Parameters of tDCS in Chronic Pain Patients

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Rehabilitation

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:

Change in pain scales [ Time Frame: Measured for approximately 5 weeks ] [ Designated as safety issue: No ]
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 Outcome Measures:

Change in cutaneous hyperalgesia/allodynia [ Time Frame: Measured for approximately 5 weeks. ] [ Designated as safety issue: No ]
To investigate whether treatment with active anodal hd-tDCS alters the phenomenon of central sensitization as indexed by cutaneous allodynia and hyperalgesia by measuring whether anodal tDCS changes the threshold for pain and perception as compared with sham and cathodal hd-tDCS. The subject's pain threshold will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Estimated Enrollment:	24
Study Start Date:	April 2011
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active Anodal HD-tDCS Subject will receive one 20-minute session of active anodal HD-tDCS.	Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) 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)
Experimental: Active Cathodal HD-tDCS Subject will receive one 20-minute session of active cathodal HD-tDCS.	Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) 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)
Sham Comparator: Sham HD-tDCS Subject will receive one sham session of HD-tDCS	Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) 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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

STUDY 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402960

Contacts

Contact: Felipe Fregni, MD, PhD, MPH	617-573-2326	ffregni@partners.org
Contact: Kayleen Weaver, BA	617-573-2196	kmweaver@partners.org

Locations

United States, Massachusetts
Spaulding Rehabilitation Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Felipe Fregni, MD, PhD, MPH 617-573-2326 ffregni@partners.org
Contact: Kayleen Weaver, BA 617-573-2196 kmweaver@partners.org

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

Investigators

Principal Investigator:

Felipe Fregni, MD, PhD, MPH

Spaulding Rehabilitation Hospital (SRH)

More Information

No publications provided

Responsible Party:	Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:	NCT01402960 History of Changes
Other Study ID Numbers:	2010-p-000990
Study First Received:	June 29, 2011
Last Updated:	April 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:

High-Definition Transcranial Direct Current Stimulation

ClinicalTrials.gov processed this record on May 23, 2012