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Ear zaps + therapy: a new hope for kids with spastic cerebral palsy?

NCT ID NCT07165665

Symptom relief Sponsor: Pamukkale University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tests whether adding a gentle, non-invasive nerve stimulation on the ear (taVNS) to standard physical therapy can reduce muscle stiffness, improve movement, and boost quality of life in children with spastic cerebral palsy. Eighteen children aged 8-18 will be split into two groups: one gets therapy plus stimulation, the other gets therapy alone, twice a week for 8 weeks. Researchers will measure changes in spasticity, motor skills, heart rate variability, and daily living activities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Sep 2025

Finished

Sep 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with spastic cerebral palsy * Aged between 8 and 18 years * No chronic respiratory or cardiovascular disease * Having spasticity between 1 and 3 according to the Modified Ashworth Scale (MAS) * Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS) * Sufficient cognitive ability to participate in the study and complete assessments * No previous vagus nerve stimulation and no contraindications for the procedure * No congenital or acquired cardiovascular disease * Written informed consent obtained from parents or legal guardians Exclusion Criteria: * History of congenital or acquired severe cardiovascular or pulmonary disease * Requirement of mechanical ventilation due to respiratory failure * History of epilepsy or active seizures * Previous vagus nerve stimulation * Inability to complete assessments due to severe cognitive impairment * Having spasticity of 0 or 4 according to the Modified Ashworth Scale (MAS) * Classified as Level IV-V according to the Gross Motor Function Classification System (GMFCS) * Presence of skin disease in the neck or ear region or any condition preventing vagus nerve stimulation * Inability to obtain parental/legal guardian consent for participation in the study Withdrawal Criteria for Participants: Participants will be withdrawn from the study if they are unable to complete the administered tests, assessments, or questionnaires. Study Termination Criteria: The study will be concluded once the planned sample size has been reached.

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Conditions

The condition(s) this trial relates to.

cerebral palsy spastic cerebral palsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children with cerebral palsy

Contacts and locations

Locations

  • VM Medical Park Bursa Hospital

    Bursa, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.