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PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459885
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Validia Rehabilitation Centre
Information provided by (Responsible Party):
Anastasia Shulga, Helsinki University Central Hospital

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
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
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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)).


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
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Finland
BioMag laboratory, Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Validia Rehabilitation Centre
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anastasia Shulga, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03459885    
Other Study ID Numbers: UAK 1022001
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries