Status:
COMPLETED
PAS in Subacute SCI
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Spinal Cord Injuries
Spinal Cord Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04101916
Start Date
October 10 2019
End Date
January 13 2025
Last Update
March 13 2025
Active Locations (1)
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1
BioMag laboratory, Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00029