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Long-term PAS in Rehabilitation After SCI

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: NCT03045744
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : February 28, 2023
Sponsor:
Collaborators:
Validia Rehabilitation
University of Helsinki
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 two pilot 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). In this study, the investigators will administer long-term paired associative stimulation to incomplete SCI patients in a long-term manner, keeping each patient in the study for as long as continuous improvement is observed.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: long-term paired associative stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 in Rehabilitation of Spinal Cord Injury Patients
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: incomplete SCI patients Device: long-term paired associative stimulation
Paired associative stimulation (PAS) administered 3 times per week. 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 ]
  2. Daniels and Worthingham's Muscle Testing [ Time Frame: 1 month after the last stimulation session ]

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:

  • 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): NCT03045744


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
University of Helsinki
Investigators
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Principal Investigator: Anastasia Shulga, MD, PhD Helsinki University Central Hospital
More Information
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Publications of Results:

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Responsible Party: Anastasia Shulga, Principle Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03045744    
Other Study ID Numbers: ULD 8100014
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023

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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