Combining PAS to Non-invasive VNS

NCT04938284 | Completed

• 1 other identifier: UAK1022001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Plasticity

Outcome Measures

Primary Outcomes (4)

• Motor evoked potential (MEP) potentiation

  MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

  0 minutes after the stimulation protocol

• Motor evoked potential (MEP) potentiation

  MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

  30 minutes after the stimulation protocol

• Motor evoked potential (MEP) potentiation

  MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

  60 minutes after the stimulation protocol

• Motor evoked potential (MEP) potentiation

  MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

  90 minutes after the stimulation protocol

Study Arms (4)

PAS and VNS

EXPERIMENTAL

Device: PAS; Device: VNS

PAS and sham VNS

ACTIVE COMPARATOR

Device: PAS

PAS

ACTIVE COMPARATOR

Device: PAS

VNS

ACTIVE COMPARATOR

Device: VNS

Interventions

PAS DEVICE

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

PAS; PAS and VNS; PAS and sham VNS

VNS DEVICE

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

PAS and VNS; VNS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Related Publications (3)

• 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.

  PMID: 33738876 BACKGROUND

• 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.

  PMID: 26645257 BACKGROUND

• 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.

  PMID: 39258329 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 24, 2021
• Study Start: July 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

FI (1)