Spinal PlasticityNCT04938284
Combining PAS to Non-invasive VNS
A study testing PAS and VNS in people with Spinal Plasticity, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Plasticity
- What is being tested?
- PAS and VNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jul 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Plasticity
- Being tested
- PAS, VNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASDevice
Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
VNSDevice
Non-invasive vagus nerve stimulation delivered through cymba concha \& cymba cavum of the ear.
| Study group | Role | What they receive |
|---|---|---|
| PAS and VNS | Experimental | Not described Receives: Device: PAS; Device: VNS |
| PAS and sham VNS | Active comparator | Not described Receives: Device: PAS |
| PAS | Active comparator | Not described Receives: Device: PAS |
| VNS | Active comparator | Not described Receives: Device: VNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential (MEP) potentiation
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Measured: 0 minutes after the stimulation protocol
Motor evoked potential (MEP) potentiation
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Measured: 30 minutes after the stimulation protocol
Motor evoked potential (MEP) potentiation
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Measured: 60 minutes after the stimulation protocol
Motor evoked potential (MEP) potentiation
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Measured: 90 minutes after the stimulation protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal PlasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Shulga, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938284
- Sponsor's protocol ID
- UAK1022001
- Status last verified
- May 2025
- First submitted
- 11 Jun 2021
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33738876Dawson 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.
PubMed 26645257Haakana 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.
PubMed 39258329
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synergistic Effect of Paired Associative Stimulation and Vagus Nerve Stimulation on Motor-evoked Potential Potentiation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04938284
- Acronym / sponsor ID
- UAK1022001
- Conditions
- Spinal Plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASPaired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS) | Device | PAS, PAS and VNS, PAS and sham VNS |
| VNSNon-invasive vagus nerve stimulation delivered through cymba concha \& cymba cavum of the ear. | Device | PAS and VNS, VNS |
Primary outcome
Motor evoked potential (MEP) potentiation
Time frame: 0 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Motor evoked potential (MEP) potentiation
Time frame: 30 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Motor evoked potential (MEP) potentiation
Time frame: 60 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Motor evoked potential (MEP) potentiation
Time frame: 90 minutes after the stimulation protocol
MEPs are responses to transcranial magnetic stimulation recorded from target muscles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 33738876Shulga 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.
- Background: PubMed 26645257Dawson 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.
- Results publication: PubMed 39258329Haakana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAS and VNS in people with Spinal Plasticity, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potential (MEP) potentiation (time frame: 0 minutes after the stimulation protocol). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04938284, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.