Combining PAS to Non-invasive VNS

NCT ID: NCT04938284

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-12-30

Brief Summary

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Vagus nerve stimulation (VNS) and paired associative stimulation (PAS) have been shown to have efficacy in improving the results of motor rehabilitation after stroke and spinal cord injury, respectively. Here we will investigate in healthy subjects the synergistic effect of these stimulation modalities on motor-evoked potential (MEP) potentiation.

Detailed Description

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Conditions

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Spinal Plasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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PAS and VNS

Group Type EXPERIMENTAL

PAS

Intervention Type DEVICE

Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)

VNS

Intervention Type DEVICE

Non-invasive vagus nerve stimulation delivered through cymba concha \& cymba cavum of the ear.

PAS and sham VNS

Group Type ACTIVE_COMPARATOR

PAS

Intervention Type DEVICE

Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)

PAS

Group Type ACTIVE_COMPARATOR

PAS

Intervention Type DEVICE

Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)

VNS

Group Type ACTIVE_COMPARATOR

VNS

Intervention Type DEVICE

Non-invasive vagus nerve stimulation delivered through cymba concha \& cymba cavum of the ear.

Interventions

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PAS

Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)

Intervention Type DEVICE

VNS

Non-invasive vagus nerve stimulation delivered through cymba concha \& cymba cavum of the ear.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* contraindications to TMS (e.g. brain pathology, implanted devices)
* contraindications to MRI (e.g. MRI incompatible implants)
* continuous use of CNS-active drugs
* neurological, psychiatric or cardiovascular disease
* drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anastasia Shulga

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29.

Reference Type BACKGROUND
PMID: 33738876 (View on PubMed)

Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.

Reference Type BACKGROUND
PMID: 26645257 (View on PubMed)

Haakana P, Natkynmaki A, Kirveskari E, Makela JP, Kilgard MP, Tarvainen MP, Shulga A. Effects of auricular vagus nerve stimulation and electrical earlobe stimulation on motor-evoked potential changes induced by paired associative stimulation. Eur J Neurosci. 2024 Oct;60(8):5949-5965. doi: 10.1111/ejn.16539. Epub 2024 Sep 11.

Reference Type RESULT
PMID: 39258329 (View on PubMed)

Other Identifiers

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UAK1022001

Identifier Type: -

Identifier Source: org_study_id

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