- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04938284
Combining PAS to Non-invasive VNS
March 15, 2022 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
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
-
-
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Helsinki, Finland
- Helsinki University Hospital
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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
No
Genders Eligible for Study
All
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
|
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
Non-invasive vagus nerve stimulation delivered through cymba concha & cymba cavum of the ear.
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Active Comparator: PAS and sham VNS
|
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
|
Active Comparator: PAS
|
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
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Active Comparator: VNS
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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
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MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
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0 minutes after the stimulation protocol
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Motor evoked potential (MEP) potentiation
Time Frame: 30 minutes after the stimulation protocol
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MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
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30 minutes after the stimulation protocol
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Motor evoked potential (MEP) potentiation
Time Frame: 60 minutes after the stimulation protocol
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MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
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60 minutes after the stimulation protocol
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Motor evoked potential (MEP) potentiation
Time Frame: 90 minutes after the stimulation protocol
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MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
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90 minutes after the stimulation protocol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- 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.
- 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.
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)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2022
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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