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NCT Number: NCT05362422

PAS for Post-SCI Neuropathic Pain

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.

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Key information

Conditions

Spinal Cord Injury Cervical Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

long-term paired associative stimulation

Device

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 stimulation

Device

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Primary outcomes

  1. Brief Pain Inventory

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

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

  2. Brief Pain Inventory

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

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

  3. Numeric Rating Scale

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

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

  4. Numeric Rating Scale

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

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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 5, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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