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Nervus vagus stimulatie en cerebrale parese

2 november 2026 bijgewerkt door: gulay karacaoglu, Istanbul Medipol University Hospital

Acute Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Nervous System Regulation and Spasticity in Children With Spastic Cerebral Palsy: A Preliminary Study

This study investigated the acute effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic nervous system regulation and spasticity in children with spastic cerebral palsy. A total of 20 children aged 2-15 years participated in this prospective, single-group pretest-posttest study. All participants received a single 20-minute session of bilateral taVNS. Autonomic nervous system regulation was assessed using heart rate variability (HRV) parameters, while spasticity was evaluated using the Modified Ashworth Scale (MAS). Measurements were performed before and after the intervention to investigate the immediate effects of taVNS.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This prospective, single-group pretest-posttest clinical study investigated the acute effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic nervous system regulation and spasticity in children with spastic cerebral palsy (CP). The study was conducted at the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital, Türkiye, between January and March 2025.

A total of 20 children aged 2-15 years with a diagnosis of spastic cerebral palsy were included. All participants completed the study, and no dropouts occurred.

Assessment Procedures

Participants' demographic characteristics, including age, sex, height, weight, and body mass index, were recorded. Gross motor function was classified using the Gross Motor Function Classification System (GMFCS).

Spasticity was assessed using the Modified Ashworth Scale (MAS), which evaluates resistance to passive movement. Bilateral elbow flexors, wrist flexors, knee extensors, and ankle plantar flexors were assessed, resulting in eight individual scores per participant. The mean of these scores was used as the composite MAS score.

Autonomic nervous system regulation was evaluated through heart rate variability (HRV) measurements using the Elite HRV device. The recorded parameters included average heart rate, root mean square of successive differences (RMSSD), percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50), low-frequency power (LF), high-frequency power (HF), and the LF/HF ratio.

HRV measurements were obtained during a one-minute recording period in the seated position with guided breathing.

Intervention

All participants received a single 20-minute session of bilateral transcutaneous auricular vagus nerve stimulation using the Vagustim device. Electrodes were positioned on the concha and tragus regions of both ears.

Stimulation was delivered using biphasic current at a frequency of 10 Hz and a pulse width of 300 microseconds. Stimulation intensity was gradually increased to the maximum comfortable level tolerated by each participant. The mean applied intensity was 0.8 ± 0.3 mA.

Participants were positioned supine during stimulation.

Assessment Timeline

Before the intervention, participants rested in a seated position for five minutes, followed by a one-minute HRV recording and MAS assessment.

Following the 20-minute taVNS session, participants returned to a seated position and rested for five minutes before the post-intervention HRV measurement. Spasticity was subsequently reassessed using the MAS.

The primary outcomes were changes in HRV parameters and spasticity following the single taVNS session.

Statistical Analysis

Data were analyzed using IBM SPSS Statistics version 28.0. Normality was assessed using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Paired-samples t-tests were used for normally distributed variables, while Wilcoxon signed-rank tests were applied to non-normally distributed variables. Spearman correlation analysis was performed to examine associations between GMFCS levels and changes in spasticity and autonomic nervous system parameters.

Statistical significance was set at p < 0.05.

All 20 participants completed the intervention and assessments, with no missing data or reported adverse events.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 15 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Children aged 2-15 years diagnosed with spastic cerebral palsy (CP) by a physical medicine and rehabilitation specialist or neurologist.

Written informed consent provided by parents or legal guardians and willingness of the child to participate.

Clinical stability without acute illness or comorbidities that could affect autonomic function or spasticity.

Exclusion Criteria:

Severe intellectual disability preventing understanding of or participation in study procedures.

Uncontrolled cardiovascular, respiratory, or autonomic disorders (e.g., arrhythmia or severe asthma).

Presence of medical devices potentially affected by vagus nerve stimulation (e.g., pacemakers or cochlear implants).

Risk of vagus nerve stimulation interacting with antiepileptic medication or triggering epileptic seizures.

Inability of the child or parent/legal guardian to comply with the study protocol or cooperate with study procedures.

Botulinum toxin injections within the previous three months.

Initiation or dose adjustment of oral antispastic medications (e.g., baclofen, tizanidine, or diazepam) within the previous month.

Initiation of a new rehabilitation program or intensification of an existing rehabilitation program within the previous four weeks.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: nervus vagus stimulation

All 20 participants received a single 20-minute session of bilateral transcutaneous auricular vagus nerve stimulation (taVNS) using the Vagustim device. Stimulation was delivered through electrodes positioned on the concha and tragus regions of both ears, using biphasic current at a frequency of 10 Hz and a pulse width of 300 microseconds. Stimulation intensity was gradually increased to the maximum comfortable level tolerated by each participant. Spasticity and heart rate variability (HRV) parameters were assessed before and after the intervention to evaluate its acute effects.
Apparaat: nervus vagus stimulation

Transcutaneous auricular vagus nerve stimulation (taVNS) was administered bilaterally using the Vagustim device (Vagustim Medical Technologies, Istanbul, Türkiye). Participants received a single 20-minute stimulation session in the supine position. Electrodes were placed on the concha and tragus regions of both ears. Stimulation was delivered using biphasic current at a frequency of 10 Hz and a pulse width of 300 microseconds. The stimulation intensity was gradually increased to the maximum level tolerated by each participant. The mean applied stimulation intensity was 0.8 ± 0.3 mA (range: 0.4-1.5 mA).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Spasticity Assessed Using the Modified Ashworth Scale (MAS)
Tijdsspanne: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

Spasticity was assessed using the Modified Ashworth Scale (MAS), which evaluates resistance to passive movement on a scale ranging from 0 (normal muscle tone) to 4 (complete rigidity). Bilateral elbow flexors, wrist flexors, knee extensors, and ankle plantar flexors were evaluated, yielding eight individual scores per participant. The mean of these eight scores was calculated as the composite MAS score. Higher scores indicated greater spasticity. Measurements were performed before and after the intervention to assess acute changes in spasticity following a single session of transcutaneous auricular vagus nerve stimulation (taVNS).
The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic Nervous System Activity Value/RMSSD
Tijdsspanne: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device. Key parameters include:

RMSSD: Reflects parasympathetic activity and forms the basis of HRV and and is expressed in milliseconds
The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic nervous system activity/ LF Power
Tijdsspanne: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.LF Power: Indicates sympathetic activity (0.04-0.15 Hz range) and t is expressed as the square of milliseconds
The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic nervous system activity / HF Power
Tijdsspanne: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.HF Power: Represents parasympathetic activity (0.15-0.40 Hz range) and t is expressed as the square of milliseconds
The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic nervous system activity - LF/HF
Tijdsspanne: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.LF/HF Ratio: Measures sympathovagal balance.
The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Heart Rate
Tijdsspanne: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.The participants' average heart rate will be recorded in beats per minute (bpm).
The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istanbul Medipol University Hospital

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2025

Primaire voltooiing (Werkelijk)

15 maart 2025

Studie voltooiing (Werkelijk)

31 maart 2025

Studieregistratiedata

Eerst ingediend

10 maart 2025

Eerst ingediend dat voldeed aan de QC-criteria

17 maart 2025

Eerst geplaatst (Werkelijk)

18 maart 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 januari 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E-10840098-202.3.02-526

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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