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Effects of Transcranial Direct Current Stimulation (tDCS) and Visual Illusion on Chronic Pain Due to 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:
NCT01404065
First received: June 29, 2011
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to investigate the effects of Transcranial Direct Current Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects with spinal cord injury when compared to sham stimulation. The investigators will also measure changes in EEG data (alpha and beta frequencies) as well as motor cortex excitability.


Condition Intervention Phase
Chronic Pain
Spinal Cord Injury
 Procedure: Transcranial Direct Current Stimulation (tDCS)
 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: Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex Coupled With Visual Illusion 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:
  • Changes in EEG (alpha and beta activity) [ Time Frame: Measured for approximately 6 weeks ] [ Designated as safety issue: No ]
    Determine whether treatment with tDCS coupled with visual illusion change cortical activity as assessed with electroencephalography (EEG). We hypothesize that tDCS plus visual illusion increase in alpha activity and inhibit beta activity and this will be associated with pain reduction in patients with moderate to severe below-level spinal cord injury (SCI) pain. EEG measurements will take place throughout the subject's participation in the study, measured at: baseline, immediately pre- and post- stimulation and at follow-up visits for a total of approximately 6 weeks.


Secondary Outcome Measures:
  • Changes in cortical excitability [ Time Frame: Measured for approximately 6 weeks ] [ Designated as safety issue: No ]
    To investigate whether active tDCS combined with visual illusion induces changes in motor cortex and as indexed by single and paired-pulse transcranial magnetic stimulation (TMS) as compared with sham tDCS coupled with visual illusion. We will also determine whether these changes are correlated with the clinical outcome (pain reduction). TMS measurements will take place throughout the subject's participation in the study, measured at: baseline, immediately pre- and post- stimulation and at follow-up visits for a total of approximately 6 weeks.


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active tDCS + visual illusion
Subjects will receive active tDCS while watching a visual illusion movie (legs walking on a treadmill). Stimulation will last for 20 minutes.
 Procedure: Transcranial Direct Current Stimulation (tDCS)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
Other Name: low intensity 1x1 direct current stimulator
Sham Comparator: Sham tDCS + visual illusion
Subjects will receive sham tDCS stimulation (30 seconds ramp up/ramp down) while watching a visual illusion movie (legs walking on a treadmill)
 Procedure: Transcranial Direct Current Stimulation (tDCS)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
Other Name: low intensity 1x1 direct current stimulator
Healthy Subjects
Healthy subjects will receive both interventions (active and sham) in a randomized and counterbalanced order. Each stimulation session will be at least 1 week apart to prevent carry-over effects
 Procedure: Transcranial Direct Current Stimulation (tDCS)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of 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:   Yes
Criteria

STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

  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 relief - 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

Exclusion Criteria:

  1. Clinically significant or unstable medical or psychiatric disorder
  2. History of substance abuse
  3. Neuropsychiatric comorbidities, including: Documented traumatic brain injury (TBI), defined as damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia (PTA), or skull fracture, or objective neurological findings that can be reasonably attributed to TBI as assessed by the study PI
  4. Implanted devices for pain control, such as vagal or deep brain stimulators

  5. Contraindications to tDCS:

    • metal in the head
    • implanted brain medical devices
  6. Pregnancy
  7. Use of ventilators or ventilation support
  8. Complete tetraplegic lesion (no motor function in the arms) (C3 to C8) as we will be measuring the motor evoked potential in the FDI (upper limbs); only tetraplegic patients with incomplete functional status and also as defined by the ability to elicit MEP in the FDI will be able to participate in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404065

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
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: NCT01404065     History of Changes
Other Study ID Numbers: 2010-p-001978
Study First Received: June 29, 2011
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
transcranial direct current stimulation

Additional relevant MeSH terms:
Illusions
Spinal Cord Injuries
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013