Long-term PAS in Rehabilitation After SCI

May 12, 2025 updated by: Anastasia Shulga, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • BioMag laboratory, Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • incomplete SCI

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daniels and Worthingham's Muscle Testing
Time Frame: 2 days after the last stimulation session
2 days after the last stimulation session
Daniels and Worthingham's Muscle Testing
Time Frame: 1 month after the last stimulation session
1 month after the last stimulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki
Validia Rehabilitation

Investigators

  • Principal Investigator: Anastasia Shulga, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2017

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimated)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULD 8100014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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