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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

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Chronic Pain Neuropathic Pain Device: Transcranial direct current stimulation (tDCS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury.
Study Start Date : December 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Subjects will undergo 20 minutes active tDCS.
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

Sham Comparator: Sham tDCS
Subjects will undergo 20 minutes of sham stimulation.
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599767


Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
U.S. Department of Education
Investigators
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01599767     History of Changes
Other Study ID Numbers: 2011-p-002353
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
transcranial stimulation
direct current

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Chronic Pain
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases