Neuropathic Pain, Spinal Cord Injury Cervical
Conditions
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.
Interventions
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)).
DEVICEsham long-term paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory | 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 1 day after the intervention | 0-10 scale, 0 - no pain, 10 - worst possible pain. |
Countries
Finland
Outcome results
None listed