PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

Spinal Cord Injuries Clinical Trial

Official title:

Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459885
• Other study ID #: UAK 1022001
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• cervical incomplete SCI

Exclusion Criteria:

• epilepsy

• metal inclusion in the head area

• pacemaker

• hearing device

• high intracranial pressure

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries

Intervention

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)).

Locations

Country	Name	City	State
Finland	BioMag laboratory, Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Validia Rehabilitation Centre

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daniels and Worthingham's Muscle Testing	Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)	2 days after the last stimulation session
Primary	Daniels and Worthingham's Muscle Testing	leg muscles are evaluated on 0-5 scale	1 month after the last stimulation session