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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).
The active tDCS stimulation sessions will be compared to sham stimulation.
More study details will be provided by Spaulding Rehabilitation Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS/Spinal cord injury | Experimental | 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. |
|
| tDCS/Healthy subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | Stimulation will be applied at 2 mA for a total of 20 minutes. |
|
| 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) |
| 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) |
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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:
No pregnancy
Eligible to MRI according to MRI screening checklist.
No use of ventilators
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |