Neuropathic Pain Clinical Trial
Official title:
Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
Verified date | September 2023 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | September 22, 2023 |
Est. primary completion date | May 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - incomplete cervical spinal cord injury - time from injury at least 1.5 years - chronic SCI- induced neuropathic pain in the upper limb Exclusion Criteria: - 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). - 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. - Pressure ulcer affecting the subject's capability to undergo the procedure safely |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brief Pain Inventory | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 1 day after the intervention | |
Primary | Brief Pain Inventory | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 8 weeks after the intervention | |
Primary | Numeric Rating Scale | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 1 day after the intervention | |
Primary | Numeric Rating Scale | 0-10 scale, 0 - no pain, 10 - worst possible pain. | Change from baseline at 8 weeks after the intervention |
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