PAS for Post-SCI Neuropathic Pain

Study Overview
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Brief Summary
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The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.

Official Title
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Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain

Conditions
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Spinal Cord Injury Cervical, Neuropathic Pain

Intervention / Treatment
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* Device: long-term paired associative stimulation
* Device: sham long-term paired associative stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: incomplete cervical spinal cord injury time from injury at least 1.5 years chronic SCI- induced neuropathic pain in the upper limb Exclusion Criteria: Diagnosed brain damage, visible in MRI or CT. No activity in hands/fingers and no MEPs recorded from distal hand muscles. Epilepsy Metal inclusion in the head area High intracranial pressure Pacemaker Implanted hearing device Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases). Previous head or spinal cord injury affecting the motor performance of upper extremities. Congenital anomaly in the anatomical structure of spinal canal/cord or dura. Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures. Acute severe infection. Contraindications for MRI. Current severe psychiatric diseases. Current chronic drug and/or alcohol abuse. Pregnancy. Pressure ulcer affecting the subject's capability to undergo the procedure safely

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAS<br> | Device: long-term paired associative stimulation<br>* Paired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).<br>|
| Sham Comparator: SHAM<br> | Device: sham long-term paired associative stimulation<br>* Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 1 day after the intervention | 
| Brief Pain Inventory | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 8 weeks after the intervention | 
| Numeric Rating Scale | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 1 day after the intervention | 
| Numeric Rating Scale | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 8 weeks after the intervention |