- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459885
PAS for Lower Extremity Rehabilitation in Tetraplegic Patients
August 6, 2019 updated by: Anastasia Shulga, Helsinki University Central Hospital
Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia
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.
Study Overview
Status
Completed
Conditions
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
-
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Uusimaa
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Helsinki, Uusimaa, Finland, 00029
- BioMag laboratory, Helsinki University Central Hospital
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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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cervical 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PAS
The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator.
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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)).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daniels and Worthingham's Muscle Testing
Time Frame: 2 days after the last stimulation session
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Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)
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2 days after the last stimulation session
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Daniels and Worthingham's Muscle Testing
Time Frame: 1 month after the last stimulation session
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leg muscles are evaluated on 0-5 scale
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1 month after the last stimulation session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela JP. Long-term paired associative stimulation can restore voluntary control over paralyzed muscles in incomplete chronic spinal cord injury patients. Spinal Cord Ser Cases. 2016 Jul 14;2:16016. doi: 10.1038/scsandc.2016.16. eCollection 2016.
- Tolmacheva A, Savolainen S, Kirveskari E, Lioumis P, Kuusela L, Brandstack N, Ylinen A, Makela JP, Shulga A. Long-Term Paired Associative Stimulation Enhances Motor Output of the Tetraplegic Hand. J Neurotrauma. 2017 Sep 15;34(18):2668-2674. doi: 10.1089/neu.2017.4996. Epub 2017 Jul 21.
- Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Effects of Long-Term Paired Associative Stimulation on Strength of Leg Muscles and Walking in Chronic Tetraplegia: A Proof-of-Concept Pilot Study. Front Neurol. 2020 May 20;11:397. doi: 10.3389/fneur.2020.00397. eCollection 2020.
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 28, 2018
Primary Completion (ACTUAL)
June 28, 2019
Study Completion (ACTUAL)
June 28, 2019
Study Registration Dates
First Submitted
March 3, 2018
First Submitted That Met QC Criteria
March 3, 2018
First Posted (ACTUAL)
March 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAK 1022001
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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