PAS for Post-SCI Neuropathic Pain
Study Details
Study Description
Brief Summary
The investigators have 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 and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PAS
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Device: long-term paired associative stimulation
Paired associative stimulation (PAS) administered 3-5 times per week for 4 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)).
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| Sham Comparator: SHAM
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Device: sham long-term paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
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Outcome Measures
Primary Outcome Measures
- Brief Pain Inventory [Change from baseline at 1 day after the intervention]
0-10 scale, 0 - no pain, 10 - worst possible pain.
- Brief Pain Inventory [Change from baseline at 8 weeks after the intervention]
0-10 scale, 0 - no pain, 10 - worst possible pain.
- Numeric Rating Scale [Change from baseline at 1 day after the intervention]
0-10 scale, 0 - no pain, 10 - worst possible pain.
- Numeric Rating Scale [Change from baseline at 8 weeks after the intervention]
0-10 scale, 0 - no pain, 10 - worst possible pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
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incomplete cervical spinal cord injury
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time from injury at least 1.5 years
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chronic SCI- induced neuropathic pain in the upper limb
Exclusion Criteria:
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Diagnosed brain damage, visible in MRI or CT.
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No activity in hands/fingers and no MEPs recorded from distal hand muscles.
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Epilepsy
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Metal inclusion in the head area
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High intracranial pressure
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Pacemaker
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Implanted hearing device
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Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
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Previous head or spinal cord injury affecting the motor performance of upper extremities.
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Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
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Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
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Acute severe infection.
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Contraindications for MRI.
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Current severe psychiatric diseases.
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Current chronic drug and/or alcohol abuse.
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Pregnancy.
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Pressure ulcer affecting the subject's capability to undergo the procedure safely
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsinki University Hospital | Helsinki | Finland |
Sponsors and Collaborators
- Helsinki University Central Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Shulga A, Lioumis P, Kirveskari E, Savolainen S, Mäkelä JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29. Review.
- Vaalto S, Nyman AL, Shulga A. Analgesic effect of paired associative stimulation in a tetraplegic patient with severe drug-resistant neuropathic pain: a case report. Scand J Pain. 2021 May 21;21(4):831-838. doi: 10.1515/sjpain-2021-0012. Print 2021 Oct 26.
- TYH2020244