Cerebral PalsyNCT07394608
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
A study testing Non-invasive taVNS in people with Cerebral Palsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Non-invasive taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-17 years old
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)
- Jebsen Taylor Hand Function Test Score of <37.08 on the affected side at time of screening visit (will be evaluated at screening)
- Ability to communicate and follow two step commands at the time of screening
- Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent
Who cannot join
- Previous vagus nerve injury
- Less than 12 years old or greater than 18 years old
- History of left or bilateral vagotomy
- Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.
- Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:
- Acute suicidal thinking or behavior
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- History of schizophrenia, schizoaffective disorder, or delusional disorders
- History of rapid cycling bipolar disorder
- Progressive neurological diseases
- Cardiac arrhythmias or other abnormalities
- History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc.
- GMFCS score of less than II or greater than III (will be evaluated at screening)
- Jebsen Taylor Hand Function Test Score of >37.08 on the affected side at time of screening visit (will be evaluated at screening)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Charles Lazarus Children's Abilities Center
New York, New York, 10029
Jenna Tosto Mancuso, PT, DPT,NCS, 212-241-8454, jenna.tosto@mountsinai.org
David Putrino
About this study
Official title: Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial
This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Non-invasive taVNS
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive taVNSDevice
Also called Non-invasive, transauricular, vagus nerve stimulation device, Vagustim
Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive VNS | Experimental | Non-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions Receives: Device: Non-invasive taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse event and serious adverse events
Safety is assessed by adverse event.
Measured: 12 months
Secondary outcomes (8)
Number of therapy sessions complete
Number of therapy sessions complete
Measured: end of therapy visits at Day 46
Active training time per session
Number of minutes of training per session
Measured: end of therapy visits at Day 46
Number of movement repetitions completed per session
Number of movement repetitions completed per session.
Measured: end of therapy visits at Day 46
Jebsen Taylor Hand Function Test (JTHFT)
The Jebsen Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand functions that uses simulated activities of daily living (ADLs) assessed by time to completion; typically up to several minutes depending on impairment
Measured: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
BOT-2
The BOT-2 is a standardized assessment of motor proficiency in children and adolescents. It evaluates fine motor skills, manual dexterity, coordination, and motor integration through structured performance tasks.
Fine Motor Precision (Upper Extremity) scored 0-41, higher score indicates better precision Fine Motor Integration (Upper Extremity) scored 0-45, higher score indicates better integration Manual Dexterity (Upper Extremity) scored 0- 45, higher score indicates better manual dexterity.
Upper-Limb Coordination scored 0-30, higher score indicates better upper-limb coordination.
Measured: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
ABILHANDS
ABILHAND is a patient-reported outcome measure that evaluates a person's perceived manual ability to perform daily bimanual activities. It assesses how difficult activities are to perform using both hands.
The ABILHAND-Kids logit score ranges from -6 logits to +6 logits, higher score indicates better bimanual manual ability (tasks are perceived as easier).
Measured: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
Pediatric Evaluation of Disability (PEDI)
The PEDI assesses functional abilities and performance in children across three domains: self-care, mobility, and social function. It measures both capability and caregiver assistance.
Subscale range and full range uses scaled scores standardized to a 0-100 metric. Higher scores indicate better functional abilities and greater independence.
Measured: at 12 months
Pediatric Quality of Life Inventory (PedsQL)
The PedsQL is a standardized patient-reported outcome measure assessing health-related quality of life in children across domains including physical, emotional, social, and school functioning.
Subscales range and full scale scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life.
Measured: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start26 May 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394608
- Sponsor's protocol ID
- STUDY-25-01164
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial
- ClinicalTrials.gov ID
- NCT07394608
- Acronym / sponsor ID
- STUDY-25-01164
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 6 Feb 2026 (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 is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Non-invasive VNS | Experimental | Device: Non-invasive taVNSNon-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 12-17 years old
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)
- Jebsen Taylor Hand Function Test Score of <37.08 on the affected side at time of screening visit (will be evaluated at screening)
- Ability to communicate and follow two step commands at the time of screening
Key exclusion criteria (13 listed)
- Previous vagus nerve injury
- Less than 12 years old or greater than 18 years old
- History of left or bilateral vagotomy
- Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.
- Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:
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 |
|---|---|---|
| Non-invasive taVNSAlso: Non-invasive, transauricular, vagus nerve stimulation device, VagustimDevice activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE). | Device | Non-invasive VNS |
Primary outcome
Number of adverse event and serious adverse events
Time frame: 12 months
Safety is assessed by adverse event.
8 secondary outcomes
Number of therapy sessions complete
Time frame: end of therapy visits at Day 46
Active training time per session
Time frame: end of therapy visits at Day 46
Number of movement repetitions completed per session
Time frame: end of therapy visits at Day 46
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
BOT-2
Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
ABILHANDS
Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
Pediatric Evaluation of Disability (PEDI)
Time frame: at 12 months
Pediatric Quality of Life Inventory (PedsQL)
Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
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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.
David Putrino, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive taVNS in people with Cerebral Palsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Tosto Mancuso, PT, DPT,NCS (212-241-8454, jenna.tosto@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse event and serious adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.