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Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01599767
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2012
First Posted Date  ICMJE May 16, 2012
Last Update Posted Date October 26, 2018
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
Change in Pain Scale [ Time Frame: Measured for approximately 6 months ]
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic sublesional neuropathic pain due to spinal cord injury, as measured by changes in the Brief Pain Inventory (BPI) from baseline to follow-up (up to 2 months after the final stimulation session).
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
Change in Pain Scale [ Time Frame: Measured for approximately 6 months ]
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic sublesional neuropathic pain due to spinal cord injury, as measured by changes in the Brief Pain Inventory (BPI) from baseline to follow-up.
Change History Complete list of historical versions of study NCT01599767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
  • Changes in Quality of Life Scale [ Time Frame: Measured for approximately 6 months ]
    Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Satisfaction with Life Scale (SWLS), from baseline to follow-up (up to 2 months after the final stimulation session).
  • Changes in Mood Scale [ Time Frame: Measured for approximately 6 months ]
    Determine whether anodal transcranial direct current stimulation is effective in improving mood in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Patient Health Questionnaire-9 (PHQ9), from baseline to follow-up (up to 2 months after the final stimulation session).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
  • Changes in Quality of Life Scale [ Time Frame: Measured for approximately 6 months ]
    Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Satisfaction with Life Scale (SWLS), from baseline to follow-up.
  • Changes in Mood Scale [ Time Frame: Measured for approximately 6 months ]
    Determine whether anodal transcranial direct current stimulation is effective in improving mood in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Patient Health Questionnaire-9 (PHQ9), from baseline to follow-up.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury
Official Title  ICMJE Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury.
Brief Summary

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injury
  • Chronic Pain
  • Neuropathic Pain
Intervention  ICMJE Device: Transcranial direct current stimulation (tDCS)
Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Other Names:
  • 1x1 low-intensity direct current stimulator
  • Soterix Medical
Study Arms
  • Experimental: Active tDCS
    Subjects will undergo 20 minutes active tDCS.
    Intervention: Device: Transcranial direct current stimulation (tDCS)
  • Sham Comparator: Sham tDCS
    Subjects will undergo 20 minutes of sham stimulation.
    Intervention: Device: Transcranial direct current stimulation (tDCS)
Publications * Thibaut A, Carvalho S, Morse LR, Zafonte R, Fregni F. Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial. Neurosci Lett. 2017 Sep 29;658:19-26. doi: 10.1016/j.neulet.2017.08.024. Epub 2017 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
46
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2012)
120
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Over 18 years of age
  • History of moderate to severe sublesional pain

Exclusion Criteria:

  • Active alcohol or drug dependence, as self-reported
  • A history of bipolar disorder or psychosis, as self-reported
  • Inability to travel to the study site,
  • Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment [53]: carbamazepine, oxcarbazepine, phenytoin, ropinirole (Requip), pramipexole (Mirapex), and cabergoline (Dostinex),
  • The following contradictions to tDCS: implanted metal plates in the head, or deep brain stimulator (spinal cord implants, including baclofen pumps, are not a contraindication as cranial currents do not reach the spinal cord [24]).
  • Pregnancy at time of enrollment
  • Current use of ventilator.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01599767
Other Study ID Numbers  ICMJE 2011-p-002353
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Felipe Fregni, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE U.S. Department of Education
Investigators  ICMJE
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
PRS Account Spaulding Rehabilitation Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP