Back to resultsPAS for Lower Extremity Rehabilitation in Tetraplegic Patients
Primary Purpose
Spinal Cord Injuries, Spinal Cord Diseases
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- cervical incomplete SCI
Exclusion Criteria:
- epilepsy
- metal inclusion in the head area
- pacemaker
- hearing device
- high intracranial pressure
Sites / Locations
- BioMag laboratory, Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PAS
Arm Description
The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator.
Outcomes
Primary Outcome Measures
Daniels and Worthingham's Muscle Testing
Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)
Daniels and Worthingham's Muscle Testing
leg muscles are evaluated on 0-5 scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03459885
First Posted
March 3, 2018
Last Updated
August 6, 2019
Sponsor
Helsinki University Central Hospital
Collaborators
Validia Rehabilitation Centre
1. Study Identification
Unique Protocol Identification Number
NCT03459885
Brief Title
PAS for Lower Extremity Rehabilitation in Tetraplegic Patients
Official Title
Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Validia Rehabilitation Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAS
Arm Type
Experimental
Arm Description
The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator.
Intervention Type
Device
Intervention Name(s)
Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)
Intervention Description
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)).
Primary Outcome Measure Information:
Title
Daniels and Worthingham's Muscle Testing
Description
Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)
Time Frame
2 days after the last stimulation session
Title
Daniels and Worthingham's Muscle Testing
Description
leg muscles are evaluated on 0-5 scale
Time Frame
1 month after the last stimulation session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cervical incomplete SCI
Exclusion Criteria:
epilepsy
metal inclusion in the head area
pacemaker
hearing device
high intracranial pressure
Facility Information:
Facility Name
BioMag laboratory, Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28053760
Citation
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.
Results Reference
background
PubMed Identifier
28635523
Citation
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.
Results Reference
background
PubMed Identifier
32508738
Citation
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.
Results Reference
derived
Learn more about this trial
PAS for Lower Extremity Rehabilitation in Tetraplegic Patients
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