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Completed

NCT Number: NCT04101916

PAS in Subacute SCI

The investigators have recently 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 at the subacute stage, and investigate its effectiveness for upper extremity rehabilitation.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioMag laboratory, Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord
  • Cervical level injury, tetraplegia
  • Time from injury/onset of symptoms 1-4 months
  • Medical condition stable
  • Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles

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).
  • History of malignant tumor within the past 5 years.
  • 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.
  • Severe emergency care polyneuropathy
  • Pressure ulcer affecting the subject's capability to undergo the procedure safely

Treatment and study plan

Paired Associative Stimulation

Device

Paired associative stimulation (PAS) administered several times per week for 12 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 paired associative stimulation

Device

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Primary outcomes

  1. Daniels and Worthingham's Muscle Testing

    Time frame: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session

    hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)

  2. Spinal Cord Independence Measure (SCIM)

    Time frame: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session

    standard SCIM evaluation

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Paired Associative Stimulation in Subacute Spinal Cord Injury

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2019
Registry last updated
Mar 13, 2025

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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