Combining PAS to Non-invasive VNS

Study Overview
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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.

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

Conditions
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Spinal Plasticity

Intervention / Treatment
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* Device: PAS
* Device: VNS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |