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Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee

This study is currently recruiting participants.
Verified November 2012 by Spaulding Rehabilitation Hospital
Sponsor:
Collaborator:
Highland Instruments, Inc.
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01404052
First received: June 29, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.


Condition Intervention Phase
Chronic Pain
Osteoarthritis
 Device: Transcranial Direct Current Stimulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation and Transcranial Ultrasound on the Perception of Pain Due to Osteoarthritis of the Knee

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Changes in pain scale [ Time Frame: Measured for approximately 2 months ] [ Designated as safety issue: No ]
    Determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with chronic osteoarthritis pain, as measured by changes in the Visual Analogue Scale (VAS) for pain. VAS will be measured immediately before the tDCS stimulation sessions, and immediately after the tDCS stimulation sessions for the subject's duration in the trial. VAS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)


Secondary Outcome Measures:
  • Changes in cutaneous allodynia/hyperalgesia [ Time Frame: Measured for approximately 2 months ] [ Designated as safety issue: No ]
    To investigate whether stimulation with active anodal tDCS with ultrasound (applied in a diagnostic mode) alters the phenomenon of central sensitization, as indexed by cutaneous allodynia and hyperalgesia, measured by the pain perception threshold as compared with sham tDCS. Pain measurements will be measured immediately before the tDCS stimulation sessions, and immediately after for the subject's duration in the trial. Pain measurements will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)

  • Assessment of hemodynamic changes with transcranial ultrasound [ Time Frame: Measured for approximately 2 months ] [ Designated as safety issue: No ]
    To investigate hemodynamic changes in the brain that may occur due to tDCS as measured by transcranial ultrasound. Blood flow measured by TUS will be measured immediately before during and after the tDCS stimulation sessions, for the subject's duration in the trial. Blood flow measured by TUS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active tDCS + transcranial ultrasound
Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.
 Device: Transcranial Direct Current Stimulation
Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2 and an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.
Other Name: low intensity 1x1 direct current stimulator
Sham Comparator: Sham tDCS + transcranial ultrasound
Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.
 Device: Transcranial Direct Current Stimulation
Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2 and an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.
Other Name: low intensity 1x1 direct current stimulator

  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:

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old
  3. Having chronic osteoarthritis knee pain in either knee (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. Subject is pregnant.

  2. Contraindications to tDCS:

    • metal in the head
    • implanted brain medical devices

  3. Contraindications to TUS:

    • metal in the head
    • implanted brain medical devices
  4. History of alcohol or drug abuse within the past 6 months as self reported
  5. Use of carbamazepine within the past 6 months as self reported.
  6. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
  7. History of neurological disorders as self reported.
  8. History of unexplained fainting spells as self reported,
  9. History of head injury resulting in more than a momentary loss of consciousness as self reported
  10. History of neurosurgery as self reported
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404052

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
Highland Instruments, Inc.
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: NCT01404052     History of Changes
Other Study ID Numbers: 2010-p-001977
Study First Received: June 29, 2011
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
transcranial direct current stimulation
transcranial ultrasound

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013