PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

NCT ID: NCT03459885

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2019-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries Spinal Cord Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAS

The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator.

Group Type EXPERIMENTAL

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

Intervention Type 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)).

Interventions

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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)).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* cervical incomplete SCI

Exclusion Criteria

* epilepsy
* metal inclusion in the head area
* pacemaker
* hearing device
* high intracranial pressure
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Validia Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anastasia Shulga

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BioMag laboratory, Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 28053760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28635523 (View on PubMed)

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.

Reference Type RESULT
PMID: 32508738 (View on PubMed)

Other Identifiers

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UAK 1022001

Identifier Type: -

Identifier Source: org_study_id

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