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PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

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ClinicalTrials.gov Identifier: NCT03459885
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Validia Rehabilitation Centre
Information provided by (Responsible Party):
Anastasia Shulga, Helsinki University Central Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Diseases Device: Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : September 28, 2019
Estimated Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: PAS
The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator.
Device: Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography 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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cervical incomplete SCI

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459885


Locations
Finland
BioMag laboratory, Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Validia Rehabilitation Centre

Publications:
Responsible Party: Anastasia Shulga, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03459885     History of Changes
Other Study ID Numbers: UAK 1022001
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries