Combining PAS to Non-invasive VNS

May 12, 2025 updated by: Anastasia Shulga, Helsinki University Central Hospital

The Synergistic Effect of Paired Associative Stimulation and Vagus Nerve Stimulation on Motor-evoked Potential Potentiation in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAS and VNS
Device: PAS
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
Device: VNS
Non-invasive vagus nerve stimulation delivered through cymba concha & cymba cavum of the ear.
Active Comparator: PAS and sham VNS
Device: PAS
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
Active Comparator: PAS
Device: PAS
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
Active Comparator: VNS
Device: VNS
Non-invasive vagus nerve stimulation delivered through cymba concha & cymba cavum of the ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor evoked potential (MEP) potentiation
Time Frame: 0 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
0 minutes after the stimulation protocol
Motor evoked potential (MEP) potentiation
Time Frame: 30 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
30 minutes after the stimulation protocol
Motor evoked potential (MEP) potentiation
Time Frame: 60 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
60 minutes after the stimulation protocol
Motor evoked potential (MEP) potentiation
Time Frame: 90 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
90 minutes after the stimulation protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UAK1022001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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