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NCT03045744 Clinical Trial

Long-term PAS in Rehabilitation After SCI

Spinal Cord Injuries Clinical Trial

Official title:
Long-term Paired Associative Stimulation in Rehabilitation of Spinal Cord Injury Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03045744
Other study ID # ULD 8100014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date December 1, 2023

Study information
Verified date March 2024
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - incomplete SCI Exclusion Criteria: - epilepsy - metal inclusion in the head area - pacemaker - hearing device - high intracranial pressure

Study Design

Related Conditions & MeSH terms

Intervention

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)).

Locations
Country Name City State
Finland BioMag laboratory, Helsinki University Central Hospital Helsinki Uusimaa

Sponsors (3)
Lead Sponsor Collaborator
Helsinki University Central Hospital University of Helsinki, Validia Rehabilitation

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Restoration of hand function with long-term paired associative stimulation after chronic incomplete tetraplegia: a case study. Spinal Cord Ser Cases. 2019 Oct 1;5:81. doi: 10.1038/s41394-019-022 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Daniels and Worthingham's Muscle Testing 2 days after the last stimulation session
Primary Daniels and Worthingham's Muscle Testing 1 month after the last stimulation session
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