Clinical trial NCT05362422: PAS for Post-SCI Neuropathic Pain
Official title: Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Cervical
Neuropathic Pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: Change from baseline at 1 day after the intervention
measure: Brief Pain Inventory
timeFrame: Change from baseline at 8 weeks after the intervention
measure: Numeric Rating Scale
timeFrame: Change from baseline at 1 day after the intervention
measure: Numeric Rating Scale
timeFrame: Change from baseline at 8 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
References:
citation: 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.
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.