Nervus Vagus Stimulation and Cerebral Palsy

NCT06880887 | Active Not Recruiting Phase 1

• 1 other identifier: E-10840098-202.3.02-526
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

When the literature is reviewed, it is difficult to find direct research on the effects of auricular vagus nerve stimulation (aVNS) on the autonomic nervous system and spasticity in children with spastic cerebral palsy. However, there is a substantial body of literature on the potential of vagus nerve stimulation (VNS) to modulate autonomic functions. The aim of this study is to investigate the potential effects of vagus nerve stimulation, which is known to influence the autonomic nervous system, in individuals with spastic cerebral palsy and to explore its contributions to spasticity.

Conditions

Cerebral Palsy, Spastic

Keywords

autonomic nervus system activity; nervus vagus stimulation; asworth scala

Outcome Measures

Primary Outcomes (6)

• Muscle Spastisity Value

  The Modified Ashworth Scale (MAS) is a widely used tool to assess spasticity, measuring muscle tone in conditions like cerebral palsy, stroke, and spinal cord injuries. Spasticity causes abnormal muscle contractions and movement limitations. MAS evaluates muscle resistance during joint movements, grading spasticity from 0 (no spasticity) to 4 (joint movement impossible due to high muscle tone). It provides a simple, quick, and reliable method for monitoring spasticity, aiding in treatment planning and rehabilitation. Studies, such as Bohannon and Smith (1987), confirm its reliability in clinical practice, making it valuable for assessing treatment response and intervention needs.

  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

  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

  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

  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.

  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).

  The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).

Secondary Outcomes (1)

• Regression Analysis of Gross Motor Function Classification System (GMFCS) Levels

  Regression analysis will use post-stimulation data, comparing baseline GMFCS, spasticity, and autonomic activity to assess GMFCS's predictive role in vagus nerve stimulation effectiveness.

Study Arms (1)

nervus vagus stimulation

OTHER

Since the acute effect of transcutaneous auricular vagus nerve stimulation on spasticity in children with spastic cerebral palsy was to be measured, all participants received the auricular vagus nerve stimulation intervention once.

Other: nervus vagus stimulation

Interventions

nervus vagus stimulation OTHER

Vagus stimulation was applied bilaterally through the ear in a transcutaneous manner. transcutaneous auricular VNS (taVNS) was performed using the Vagustim device. The stimulation was applied for 20 minutes with a pulse width of 300 microseconds, a frequency of 10 Hz, and in a biphasic manner. The electrodes were placed on the concha and tragus parts of the ear, and the current was increased until the participant could feel it.

nervus vagus stimulation

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of spastic CP,
• Individuals aged 2-15 years,
• Written informed consent from parents or legal guardians and the willingness of the children to participate in the study,
• Clinically stable children without acute illnesses or comorbidities that could affect autonomic function or spasticity during the study period.

You may not qualify if:

• Children with severe intellectual disabilities who cannot understand or respond to the study procedures,
• Children with uncontrolled cardiovascular, respiratory, or autonomic disorders (e.g., arrhythmia, severe asthma),
• Children with devices such as pacemakers or cochlear implants that could be affected by vagus nerve stimulation,
• Children for whom vagus nerve stimulation may interact with antiepileptic drugs or affect seizures,
• Children or parents who cannot comply with the study protocol or cooperate.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Mudanya University

Bursa, Bursa, 16160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant prof.

Model Details: Since the acute effect of transcutaneous auricular vagus nerve stimulation on spasticity in children with spastic cerebral palsy was to be measured, all participants received the auricular vagus nerve stimulation intervention once.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 18, 2025
• Study Start: March 1, 2025
• Primary Completion: April 15, 2025
• Study Completion: May 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

TU (1)