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PAS for Post-SCI Neuropathic Pain

H

Helsinki University Central Hospital (HUCH)

Status

Completed

Conditions

Neuropathic Pain
Spinal Cord Injury Cervical

Treatments

Device: long-term paired associative stimulation
Device: sham long-term paired associative stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05362422
TYH2020244

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

5 participants in 2 patient groups

PAS
Experimental group
Treatment:
Device: long-term paired associative stimulation
SHAM
Sham Comparator group
Treatment:
Device: sham long-term paired associative stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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