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Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury

This study is currently recruiting participants.
Verified April 2013 by Spaulding Rehabilitation Hospital
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01112774
First received: April 20, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury.

We will also determine whether these changes are correlated with the clinical outcome (pain reduction).


Condition Intervention Phase
Spinal Cord Injury
 Device: Transcranial direct current stimulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Neurophysiological activity changes after treatment with tDCS [ Time Frame: baseline, 2 weeks treatment and follow up (2 weeks) ] [ Designated as safety issue: No ]
    Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)


Secondary Outcome Measures:
  • Pain changes [ Time Frame: Baseline, 2 weeks treatment and follow up (2 weeks) ] [ Designated as safety issue: No ]
    (i) Demographic Data; (ii) Visual analog scale (VAS) for pain; (iii) Analgesic use; (iv) Quality of Life Scale (QOLS); (v) Patient Global Assessment (PGA); (vi) Clinical Global Impression (CGI); (vii) Beck Depression Inventory (BDI); (viii) Visual Analog Scale (VAS) for anxiety; (ix) tDCS Side Effects Questionnaire; (x) Mini-mental status exam; and (xi) Validation of Blinding


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS/Spinal cord injury
Subjects will be randomized to receive 10 sessions of either active or sham tDCS. Stimulation will be given on consecutive days (Monday- Friday) at 2 mA over the primary motor cortex area.
 Device: Transcranial direct current stimulation
Stimulation will be applied at 2 mA for a total of 20 minutes.
Other Name: electrical stimulation, tDCS
Experimental: tDCS/Healthy subjects
Subjects will receive 2 sessions of stimulation: one active and one sham tDCS on two separate visits. The order in which they receive the stimulation will be randomized. Stimulation parameters will be at 2 mA for a total of 20 minutes.
 Device: Transcranial direct current stimulation
Stimulation will be applied at 2 mA for a total of 20 minutes.
Other Name: electrical stimulation, tDCS

Detailed Description:

The active tDCS stimulation sessions will be compared to sham stimulation.

More study details will be provided by Spaulding Rehabilitation Hospital.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old
  3. with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
  4. stable chronic pain for at least the three preceding months(for spinal cord injury only)
  5. score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment(for spinal cord injury only)
  6. refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)
  7. pain is not attributable to other causes, such as peripheral inflammation.
  8. No clinically significant or unstable medical or psychiatric disorder
  9. No history of substance abuse
  10. No neuropsychiatric comorbidity
  11. No implanted devices for pain control, such as vagal or deep brain stimulators

  12. No contraindications to tDCS:

    • metal in the head
    • implanted brain medical devices
  13. No pregnancy
  14. Eligible to MRI according to MRI screening checklist.
  15. No use of ventilators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112774

Contacts
Contact: Kayleen M Weaver, BA 617 573 2196 kmweaver@partners.org
Contact: Felipe Fregni, MD, PhD 617 573 2326 ffregni@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Felipe Fregni, MD, Phd     617-573-2326     ffregni@neuromodulationlab.org    
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01112774     History of Changes
Other Study ID Numbers: 2010p000190
Study First Received: April 20, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
Transcranial direct current stimulation
Spinal cord injury
Chronic pain
Brain excitability

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013