Last updated: February 6, 2024
Sponsor: New York State Institute for Basic Research
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cerebral Palsy
Learning Disorders
Asperger's Disorder
Treatment
Vagus Nerve Stimulation
Clinical Study ID
NCT06259201
NYInstitute
Ages 12-40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Children and adults aged 12-40 with intellectual and developmental disability (IDD)and/or autism spectrum disorder (ASD). Participants who are decisionally-impaired willbe eligible with assent.
- Able to tolerate wearing an Apple Watch, EEG, and sit for a neurocognitive test
- Be on a stable dose of psychotropic medication for at least one month prior toenrollment
- Agree not to initiate new or change existing medications or behavior intervention
Exclusion
Exclusion Criteria:
- Have an active implantable medical device (e.g., pacemaker, implanted hearing aid,etc.) or a metallic device, such as a stent, bone plate, or bone screw
- Have a comorbid physical or psychiatric disorder which would disrupt ability totolerate vagal stimulation or comply with study demands (e.g., insulin dependentdiabetes, bipolar, etc.)
- Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy,neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia)
- Current or past history of neurological disorders or trauma, including uncontrolledepilepsy and head injury.
- Current or recent (within 12 months) participation in a clinical trial of a drug or amedical device.
- Use of drugs (within 4 weeks) that affect the autonomic nervous system (beta blockers,beta stimulant, etc.).
- Use of marijuana (including medical marijuana) for any indication
- Any condition per the investigators' clinical judgment that precludes participation inthe study (e.g., pregnancy).
- Lack of capacity to consent and without a legally authorized representative (LAR) whois a parent, spouse, or an adult child.
- Living in a residential program (e.g., group home)
- Wards of state
Study Design
Total Participants: 75
Treatment Group(s): 1
Primary Treatment: Vagus Nerve Stimulation
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
New York State Psychiatric Institute
New York, New York 10032
United StatesSite Not Available
New York State Institute for Basic Research
Staten Island, New York 10314
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.