NCT07394608 Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
| NCT ID | NCT07394608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-04 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-04 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria: * 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 Exclusion criteria: * 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 * 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)
Contact & Investigator
David Putrino, PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07394608 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07394608 currently recruiting?
Yes, NCT07394608 is actively recruiting participants. Contact the research team at jenna.tosto@mountsinai.org for enrollment information.
Where is the NCT07394608 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07394608 clinical trial?
NCT07394608 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is David Putrino, PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 10 participants.
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