Spinal Cord Injury
Conditions
Keywords
Transcranial direct current stimulation, Spinal cord injury, Chronic pain, Brain excitability
Brief summary
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
The active tDCS stimulation sessions will be compared to sham stimulation. More study details will be provided by Spaulding Rehabilitation Hospital.
Interventions
DEVICETranscranial direct current stimulation
Stimulation will be applied at 2 mA for a total of 20 minutes.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurophysiological activity changes after treatment with tDCS | baseline, 2 weeks treatment and follow up (2 weeks) | Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain changes | Baseline, 2 weeks treatment and follow up (2 weeks) | (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 |
Countries
United States
Outcome results
None listed