PAS in Subacute SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2025-01-13

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.

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Detailed Description

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Conditions

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Spinal Cord Injuries Spinal Cord Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Paired Associative Stimulation

Group Type EXPERIMENTAL

Paired associative stimulation

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham paired associative stimulation

Intervention Type DEVICE

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Interventions

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Paired associative stimulation

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)).

Intervention Type DEVICE

Sham paired associative stimulation

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No