PAS for Post-SCI Neuropathic Pain

Helsinki University Central Hospital5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Cord Injury Cervical Neuropathic Pain

Interventions

long-term paired associative stimulationDEVICE

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)).

sham long-term paired associative stimulationDEVICE

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Brief Pain Inventory

0-10 scale, 0 - no pain, 10 - worst possible pain.

Time frame: Change from baseline at 1 day after the intervention

Brief Pain Inventory

0-10 scale, 0 - no pain, 10 - worst possible pain.

Time frame: Change from baseline at 8 weeks after the intervention

Numeric Rating Scale

0-10 scale, 0 - no pain, 10 - worst possible pain.

Time frame: Change from baseline at 1 day after the intervention

Numeric Rating Scale

0-10 scale, 0 - no pain, 10 - worst possible pain.

Time frame: Change from baseline at 8 weeks after the intervention

Data from ClinicalTrials.gov

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