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

• ClinicalTrials.gov Identifier: NCT01402960
• Recruitment Status: Completed
• First Posted: July 26, 2011
• Last Update Posted: April 24, 2020
• Sponsor: Spaulding Rehabilitation Hospital
• Information provided by (Responsible Party): Felipe Fregni, Spaulding Rehabilitation Hospital

Study Description

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

• 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

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

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

• 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

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

• Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT01402960
• Other Study ID Numbers: 2010-p-000990
• First Posted: July 26, 2011
• Last Update Posted: April 24, 2020
• Last Verified: April 2020

• 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