Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
1 other identifier
interventional
5
1 country
1
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). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedSeptember 25, 2019
September 1, 2019
1.2 years
April 1, 2017
September 23, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Daniels and Worthingham's Muscle Testing
each hand muscle is evaluated on 0-5 scale
2 days after the last stimulation session
Daniels and Worthingham's Muscle Testing
each hand muscle is evaluated on 0-5 scale
1 month after the last stimulation session
Study Arms (2)
Long-term PAS
EXPERIMENTALThe intervention is given to one hand only
No intervention
NO INTERVENTIONContralateral hand of the same patient
Interventions
Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. 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)).
Eligibility Criteria
You may qualify if:
- incomplete SCI of non-traumatic origin
You may not qualify if:
- epilepsy
- pacemaker
- hearing device
- high intracranial pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Validia Rehabilitation Centercollaborator
- University of Helsinkicollaborator
Study Sites (1)
BioMag laboratory
Helsinki, Finland
Related Publications (1)
Tolmacheva A, Savolainen S, Kirveskari E, Brandstack N, Makela JP, Shulga A. Paired associative stimulation improves hand function after non-traumatic spinal cord injury: A case series. Clin Neurophysiol Pract. 2019 Aug 13;4:178-183. doi: 10.1016/j.cnp.2019.07.002. eCollection 2019.
PMID: 31886442RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 1, 2017
First Posted
April 7, 2017
Study Start
March 31, 2017
Primary Completion
May 27, 2018
Study Completion
October 30, 2018
Last Updated
September 25, 2019
Record last verified: 2019-09