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Completed

NCT Number: NCT03459885

PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

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 (1,2). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and investigate its effectiveness for lower 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–70 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

  • cervical incomplete SCI

Exclusion criteria

  • epilepsy
  • metal inclusion in the head area
  • pacemaker
  • hearing device
  • high intracranial pressure

Treatment and study plan

Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)

Device

Paired associative stimulation (PAS) administered several times per week for 8 weeks to lower 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)).

Primary outcomes

  1. Daniels and Worthingham's Muscle Testing

    Time frame: 2 days after the last stimulation session

    Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)

  2. Daniels and Worthingham's Muscle Testing

    Time frame: 1 month after the last stimulation session

    leg muscles are evaluated on 0-5 scale

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Validia Rehabilitation Centre

Registry information

Official study title

Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2018
Registry last updated
May 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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