Cerebral Palsy, SpasticNCT06880887
Nervus Vagus Stimulation and Cerebral Palsy
A study testing nervus vagus stimulation in people with Cerebral Palsy, Spastic, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- nervus vagus stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 31 Mar 2025
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- nervus vagus stimulation
- Keywords
- autonomic nervus system activity, nervus vagus stimulation, asworth scala
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nervus vagus stimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| nervus vagus stimulation | Experimental | 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. Receives: Device: nervus vagus stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity Assessed Using the Modified Ashworth Scale (MAS)
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).
Measured: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic Nervous System Activity Value/RMSSD
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
Measured: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic nervous system activity/ LF Power
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
Measured: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic nervous system activity / HF Power
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
Measured: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Autonomic nervous system activity - LF/HF
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.
Measured: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Heart Rate
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).
Measured: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jan 2025
- Primary completion15 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study employed a prospective, single-group pretest-posttest design. All 20 participants received a single 20-minute session of bilateral transcutaneous auricular vagus nerve stimulation (taVNS). Spasticity and autonomic nervous system regulation were assessed before and after the intervention using the Modified Ashworth Scale (MAS) and heart rate variability (HRV) parameters, respectively. No control or sham stimulation group was included.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulay karacaoglu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880887
- Sponsor's protocol ID
- E-10840098-202.3.02-526
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yalcin G, Acar G, Kavak MF, Kulekcioglu S, Ozden AV. Acute Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Nervous System Regulation and Spasticity in Children with Spastic Cerebral Palsy: A Preliminary Study. Biomedicines. 2026 Jun 18;14(6):1370. doi: 10.3390/biomedicines14061370.
PubMed 42351798
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Nervous System Regulation and Spasticity in Children With Spastic Cerebral Palsy: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06880887
- Acronym / sponsor ID
- E-10840098-202.3.02-526
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- autonomic nervus system activity, nervus vagus stimulation, asworth scala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Mar 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study employed a prospective, single-group pretest-posttest design. All 20 participants received a single 20-minute session of bilateral transcutaneous auricular vagus nerve stimulation (taVNS). Spasticity and autonomic nervous system regulation were assessed before and after the intervention using the Modified Ashworth Scale (MAS) and heart rate variability (HRV) parameters, respectively. No control or sham stimulation group was included.
| Arm | Type | Receives |
|---|---|---|
| nervus vagus stimulation | Experimental | Device: nervus vagus stimulationAll 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. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| nervus vagus stimulationTranscutaneous 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). | Device | nervus vagus stimulation |
Primary outcome
Spasticity Assessed Using the Modified Ashworth Scale (MAS)
Time frame: 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).
Autonomic Nervous System Activity Value/RMSSD
Time frame: 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
Autonomic nervous system activity/ LF Power
Time frame: 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
Autonomic nervous system activity / HF Power
Time frame: 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
Autonomic nervous system activity - LF/HF
Time frame: 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.
Heart Rate
Time frame: 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).
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 4 Nov 2026.
- Derived from this study: PubMed 42351798Yalcin G, Acar G, Kavak MF, Kulekcioglu S, Ozden AV. Acute Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Nervous System Regulation and Spasticity in Children with Spastic Cerebral Palsy: A Preliminary Study. Biomedicines. 2026 Jun 18;14(6):1370. doi: 10.3390/biomedicines14061370.
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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 nervus vagus stimulation in people with Cerebral Palsy, Spastic, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 4 Nov 2026. 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 Turkey (Türkiye). 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?
Spasticity Assessed Using the Modified Ashworth Scale (MAS) (time frame: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).). The study lists 6 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 NCT06880887, which also lists 1 linked publication.
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 4 Nov 2026.