Combining PAS to Non-invasive VNS

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04938284
Collaborator
(none)
10
1
4
6
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PAS
  • Device: VNS
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
The Synergistic Effect of Paired Associative Stimulation and Vagus Nerve Stimulation on Motor-evoked Potential Potentiation in Healthy Subjects
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Motor evoked potential (MEP) potentiation [0 minutes after the stimulation protocol]

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

  2. Motor evoked potential (MEP) potentiation [30 minutes after the stimulation protocol]

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

  3. Motor evoked potential (MEP) potentiation [60 minutes after the stimulation protocol]

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

  4. Motor evoked potential (MEP) potentiation [90 minutes after the stimulation protocol]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Hospital Helsinki Finland

Sponsors and Collaborators

  • Helsinki University Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anastasia Shulga, Head of Department, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04938284
Other Study ID Numbers:
  • UAK1022001
First Posted:
Jun 24, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 16, 2022