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Long-term PAS in Rehabilitation After SCI

Primary Purpose

Spinal Cord Injuries

Status
Active
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 Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

incomplete SCI patients

Arm Description

Outcomes

Primary Outcome Measures

Daniels and Worthingham's Muscle Testing
Daniels and Worthingham's Muscle Testing

Secondary Outcome Measures

Full Information

First Posted
February 2, 2017
Last Updated
September 22, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
Validia Rehabilitation, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT03045744
Brief Title
Long-term PAS in Rehabilitation After SCI
Official Title
Long-term Paired Associative Stimulation in Rehabilitation of Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
incomplete SCI patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
long-term paired associative stimulation
Intervention Description
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)).
Primary Outcome Measure Information:
Title
Daniels and Worthingham's Muscle Testing
Time Frame
2 days after the last stimulation session
Title
Daniels and Worthingham's Muscle Testing
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: incomplete SCI Exclusion Criteria: epilepsy metal inclusion in the head area pacemaker hearing device high intracranial pressure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Shulga, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
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
31632739
Citation
Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Restoration of hand function with long-term paired associative stimulation after chronic incomplete tetraplegia: a case study. Spinal Cord Ser Cases. 2019 Oct 1;5:81. doi: 10.1038/s41394-019-0225-5. eCollection 2019.
Results Reference
result

Learn more about this trial

Long-term PAS in Rehabilitation After SCI

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