PAS in Subacute SCI

Study Overview
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Brief Summary
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The investigators have recently 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 at the subacute stage, and investigate its effectiveness for upper extremity rehabilitation.

Official Title
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Paired Associative Stimulation in Subacute Spinal Cord Injury

Conditions
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Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Device: Paired associative stimulation
* Device: Sham paired associative stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord Cervical level injury, tetraplegia Time from injury/onset of symptoms 1-4 months Medical condition stable Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles 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). History of malignant tumor within the past 5 years. 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. Severe emergency care polyneuropathy 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: Parallel Assignment
Interventional Model Description: The aim is 20 participants and the anticipated dropout percentage is 20%, therefore maximum number of randomized patients will be 24. If there will be no dropouts, only 20 patients will be recruited.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paired Associative Stimulation<br> | Device: Paired associative stimulation<br>* Paired associative stimulation (PAS) administered several times per week for 12 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 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 |
| --- | --- | --- |
| Daniels and Worthingham's Muscle Testing | hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal) | Change from baseline score immediately after, 6 months after and 1 year after last stimulation session | 
| Spinal Cord Independence Measure (SCIM) | standard SCIM evaluation | Change from baseline score immediately after, 6 months after and 1 year after last stimulation session |