Long-term PAS in Rehabilitation After SCI

NCT ID: NCT03045744

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

2017-02-10

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

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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incomplete SCI patients

Group Type EXPERIMENTAL

long-term paired associative stimulation

Intervention Type DEVICE

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)).

Interventions

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long-term paired associative stimulation

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)).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

UNKNOWN

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anastasia Shulga

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anastasia Shulga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

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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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.

Reference Type RESULT
PMID: 31632739 (View on PubMed)

Holopainen K, Tolmacheva A, Bersch I, Haakana P, Pohjonen M, Kirveskari E, Arokoski J, Shulga A. Stable improvement in hand muscle strength in incomplete spinal cord injury patients by long-term paired associative stimulation-a case series study. Front Neurol. 2025 Feb 4;16:1486591. doi: 10.3389/fneur.2025.1486591. eCollection 2025.

Reference Type RESULT
PMID: 39968455 (View on PubMed)

Other Identifiers

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ULD 8100014

Identifier Type: -

Identifier Source: org_study_id

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