PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

NCT03459885 | Completed

• 1 other identifier: UAK 1022001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 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 (1,2). 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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• Daniels and Worthingham's Muscle Testing

  leg muscles are evaluated on 0-5 scale

  1 month after the last stimulation session

Study Arms (1)

PAS

EXPERIMENTAL

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)

Interventions

Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device) 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)).

PAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cervical incomplete SCI

You may not qualify if:

• epilepsy
• pacemaker
• hearing device
• high intracranial pressure

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Validia Rehabilitation Centre: collaborator

Study Sites (1)

BioMag laboratory, Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (3)

• Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela 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.

  PMID: 28053760 BACKGROUND

• Tolmacheva A, Savolainen S, Kirveskari E, Lioumis P, Kuusela L, Brandstack N, Ylinen A, Makela 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.

  PMID: 28635523 BACKGROUND

• Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Effects of Long-Term Paired Associative Stimulation on Strength of Leg Muscles and Walking in Chronic Tetraplegia: A Proof-of-Concept Pilot Study. Front Neurol. 2020 May 20;11:397. doi: 10.3389/fneur.2020.00397. eCollection 2020.

  PMID: 32508738 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 9, 2018
• Study Start: February 28, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

FI (1)