PAS for Lower Extremity Rehabilitation in Tetraplegic Patients
Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03459885
Collaborator
Validia Rehabilitation Centre (Other)
5
1
1
15.9
0.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia
Actual Study Start Date
:
Feb 28, 2018
Actual Primary Completion Date
:
Jun 28, 2019
Actual Study Completion Date
:
Jun 28, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PAS The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator. |
Device: Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)
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)).
|
Outcome Measures
Primary Outcome Measures
- Daniels and Worthingham's Muscle Testing [2 days after the last stimulation session]
Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)
- Daniels and Worthingham's Muscle Testing [1 month after the last stimulation session]
leg muscles are evaluated on 0-5 scale
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- cervical incomplete SCI
Exclusion Criteria:
-
epilepsy
-
metal inclusion in the head area
-
pacemaker
-
hearing device
-
high intracranial pressure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BioMag laboratory, Helsinki University Central Hospital | Helsinki | Uusimaa | Finland | 00029 |
Sponsors and Collaborators
- Helsinki University Central Hospital
- Validia Rehabilitation Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Mäkelä 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, Mäkelä 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.
Responsible Party:
Anastasia Shulga,
Principal Investigator,
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT03459885
Other Study ID Numbers:
- UAK 1022001
First Posted:
Mar 9, 2018
Last Update Posted:
Aug 7, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: