Spinal Cord Injuries, Spinal Cord Diseases
Conditions
Brief summary
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.
Interventions
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 transcranial magnetic stimulation and sham peripheral nerve stimulation.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daniels and Worthingham's Muscle Testing | Change from baseline score immediately after, 6 months after and 1 year after last stimulation session | hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal) |
| Spinal Cord Independence Measure (SCIM) | Change from baseline score immediately after, 6 months after and 1 year after last stimulation session | standard SCIM evaluation |
Countries
Finland
Outcome results
None listed