- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112774
Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury
Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The active tDCS stimulation sessions will be compared to sham stimulation.
More study details will be provided by Spaulding Rehabilitation Hospital.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Spaulding Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)
- Providing informed consent to participate in the study
- 18 to 64 years old
- with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
- stable chronic pain for at least the three preceding months(for spinal cord injury only)
- 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)
- 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)
- pain is not attributable to other causes, such as peripheral inflammation.
- No clinically significant or unstable medical or psychiatric disorder
- No history of substance abuse
- No neuropsychiatric comorbidity
- No implanted devices for pain control, such as vagal or deep brain stimulators
No contraindications to tDCS:
- metal in the head
- implanted brain medical devices
- No pregnancy
- Eligible to MRI according to MRI screening checklist.
- No use of ventilators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Stimulation will be applied at 2 mA for a total of 20 minutes.
Other Names:
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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.
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Stimulation will be applied at 2 mA for a total of 20 minutes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurophysiological activity changes after treatment with tDCS
Time Frame: baseline, 2 weeks treatment and follow up (2 weeks)
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Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)
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baseline, 2 weeks treatment and follow up (2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain changes
Time Frame: Baseline, 2 weeks treatment and follow up (2 weeks)
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(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
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Baseline, 2 weeks treatment and follow up (2 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Felipe Fregni, PhD, Spaulding Rehabilitation Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010p000190
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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