Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Study Overview
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Brief Summary
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This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.

Detailed Description
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This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of three groups by chance. Two groups will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change.

Official Title
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Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Conditions
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Pain, Neuropathic, Complex Regional Pain Syndromes, Phantom Limb Pain, Spinal Cord Injuries

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Have chronic (>12 months) neuropathic pain, including but not limited to complex regional pain syndrome, phantom limb pain, or pain of neurogenic origin following spinal cord injury Exclusion Criteria: History of seizures or epilepsy Addition or change in the dosage of drugs now to interfere with pain within 1 month of enrollment Untreated depression History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness Positive pregnancy test or being of childbearing age and not using appropriate contraception Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS of DLPFC<br>Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left dorsolateral prefrontal cortex (DLPFC). Subjects will undergo stimulation once a day for 10 consecutive weekdays. | Device: transcranial direct current stimulation<br> <br> |
| Experimental: tDCS of M1<br>Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left primary motor cortex (M1). Subjects will undergo stimulation once a day for 10 consecutive weekdays. | Device: transcranial direct current stimulation<br> <br> |
| Sham Comparator: Sham tDCS<br>Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays. | Device: transcranial direct current stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in McGill Pain Questionnaire from baseline 1 and 2 average | This self-reported assessment measures intensity and quality of pain. Scores can range from 0 to 45. A decrease in score indicates an improvement in pain. | Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short-Form 36 Health Survey from baseline 1 and 2 average | This self-reported assessment provides information regarding an individual's perception of their health and quality of life. Scores range from 0 to 100. An increase in score indicates an improvement in perceived health and quality of life. | Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroplasticity, rehabilitation, transcranial direct current stimulation