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Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

Primary Purpose

Spinal Cord Diseases, Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
long-term paired associative stimulation
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • incomplete SCI of non-traumatic origin

Exclusion Criteria:

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

Sites / Locations

  • BioMag laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Long-term PAS

No intervention

Arm Description

The intervention is given to one hand only

Contralateral hand of the same patient

Outcomes

Primary Outcome Measures

Daniels and Worthingham's Muscle Testing
each hand muscle is evaluated on 0-5 scale
Daniels and Worthingham's Muscle Testing
each hand muscle is evaluated on 0-5 scale

Secondary Outcome Measures

Full Information

First Posted
April 1, 2017
Last Updated
September 23, 2019
Sponsor
Helsinki University Central Hospital
Collaborators
Validia Rehabilitation Center, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT03104803
Brief Title
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
Official Title
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
May 27, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Validia Rehabilitation Center, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
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). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases, Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long-term PAS
Arm Type
Experimental
Arm Description
The intervention is given to one hand only
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Contralateral hand of the same patient
Intervention Type
Device
Intervention Name(s)
long-term paired associative stimulation
Intervention Description
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)).
Primary Outcome Measure Information:
Title
Daniels and Worthingham's Muscle Testing
Description
each hand muscle is evaluated on 0-5 scale
Time Frame
2 days after the last stimulation session
Title
Daniels and Worthingham's Muscle Testing
Description
each hand muscle is 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
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: incomplete SCI of non-traumatic origin Exclusion Criteria: epilepsy metal inclusion in the head area pacemaker hearing device high intracranial pressure
Facility Information:
Facility Name
BioMag laboratory
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31886442
Citation
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.
Results Reference
result

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Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

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