PAS for Post-SCI Neuropathic Pain

Not Applicable

Completed

• Conditions: Neuropathic Pain; Spinal Cord Injury Cervical
• Interventions: Device: sham long-term paired associative stimulation; Device: long-term paired associative stimulation

• Registration Number: NCT05362422
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-22
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Primary Completion: 2023-05-22
• Status Verified: 2023-09
• Study Completion: 2023-09-22
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SHAM	sham long-term paired associative stimulation	-
PAS	long-term paired associative stimulation	-

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	Change from baseline at 8 weeks 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.

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland