PAS in Subacute SCI

N/ACompletedNCT04101916

Helsinki University Central Hospital18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Cord Injuries Spinal Cord Diseases

Interventions

Paired associative stimulationDEVICE

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)).

Sham paired associative stimulationDEVICE

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord 2. Cervical level injury, tetraplegia 3. Time from injury/onset of symptoms 1-4 months 4. Medical condition stable 5. Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles Exclusion Criteria: 1. Diagnosed brain damage, visible in MRI or CT. 2. No activity in hands/fingers and no MEPs recorded from distal hand muscles. 3. Epilepsy 4. Metal inclusion in the head area 5. High intracranial pressure 6. Pacemaker 7. Implanted hearing device 8. Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases). 9. History of malignant tumor within the past 5 years. 10. Previous head or spinal cord injury affecting the motor performance of upper extremities. 11. Congenital anomaly in the anatomical structure of spinal canal/cord or dura. 12. Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures. 13. Acute severe infection. 14. Contraindications for MRI. 15. Current severe psychiatric diseases. 16. Current chronic drug and/or alcohol abuse. 17. Pregnancy. 18. Severe emergency care polyneuropathy 19. Pressure ulcer affecting the subject's capability to undergo the procedure safely

Locations (1)

BioMag laboratory, Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Outcomes

Primary Outcomes

Daniels and Worthingham's Muscle Testing

hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)

Time frame: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session

Spinal Cord Independence Measure (SCIM)

standard SCIM evaluation

Time frame: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session

Data from ClinicalTrials.gov

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