Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Device Feasibility
Official Title:	Exploration of Parameters of tDCS in Chronic Pain Patients
Study Start Date :	April 2011
Actual Primary Completion Date :	February 2012
Actual Study Completion Date :	February 13, 2013

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in cutaneous hyperalgesia/allodynia [ Time Frame: Measured for approximately 5 weeks. ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel pain as self reported

Exclusion Criteria:

1. Pregnancy

2. Contraindications to tDCS

   • metal in the head
   • implanted brain medical devices
3. History of alcohol or drug abuse within the past 6 months as self reported
4. Use of carbamazepine within the past 6 months as self reported.
5. Severe depression (with a score of >30 in the Beck Depression Inventory)
6. History of neurological disorders as self reported.
7. History of unexplained fainting spells as self reported,
8. History of head injury resulting in more than a momentary loss of consciousness as self reported
9. History of neurosurgery as self reported

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

Investigators

Principal Investigator:	Felipe Fregni, MD, PhD, MPH	Spaulding Rehabilitation Hospital (SRH)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:	NCT01402960 History of Changes
Other Study ID Numbers:	2010-p-000990
First Posted:	July 26, 2011
Last Update Posted:	March 21, 2017
Last Verified:	March 2017

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

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:

High-Definition Transcranial Direct Current Stimulation

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms