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

Study Overview
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Brief Summary
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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).

Detailed Description
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The active tDCS stimulation sessions will be compared to sham stimulation. More study details will be provided by Spaulding Rehabilitation Hospital.

Official Title
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Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS/Spinal cord injury<br>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<br>* Stimulation will be applied at 2 mA for a total of 20 minutes.<br>* Other names: electrical stimulation, tDCS;|
| Experimental: tDCS/Healthy subjects<br>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<br>* Stimulation will be applied at 2 mA for a total of 20 minutes.<br>* Other names: electrical stimulation, tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological activity changes after treatment with tDCS | Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS) | baseline, 2 weeks treatment and follow up (2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain changes | (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 | Baseline, 2 weeks treatment and follow up (2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial direct current stimulation, Spinal cord injury, Chronic pain, Brain excitability