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New treatment option for Cerebral Palsy
Official title Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
ClinicalTrials.gov ID: NCT07394608
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.