Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259201
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-07-07
Brief Title:
Vagus Nerve Stimulator for Autism and Other Developmental Disorders
Sponsor:
New York State Institute for Basic Research
Organization:
New York State Institute for Basic Research
Study Overview
Official Title:
Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VNS
Brief Summary:
The goal of this flexible single-subject design vagus nerve stimulation VNS study is to examine the behavioral cognitive and biorhythmic effects of VNS in children and adults with autism and developmental disabilities The main aims are
Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials
Examine the effects of VNS on a broad range of symptoms
Participants will select between 1 2 or 3 months of daily VNS treatment and complete study visits each month
Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials
Examine the effects of VNS on a broad range of symptoms
Participants will select between 1 2 or 3 months of daily VNS treatment and complete study visits each month
Detailed Description:
Intellectual and developmental disabilities IDD cover a wide variety of disorders Although we know the causes of some of the disorders and some of them could even be prevented eg lead exposure most causes remain unknown Without having a clear understanding of the causes prevention is very difficult to achieve Previous studies have shown abnormal autonomic nervous system ANS regulations in young children with autism spectrum disorder ASD and these abnormalities are also observed during sleep ANS is the part of the nervous system that controls the unconscious bodily functions such as breathing heart beating and digestion
The vagus nerve strongly influences these autonomic functions including digestion breathing heart rate variability and metabolic function and central nervous system CNS activity that affect mood pain stress management sleep and even memory and cognitive functions The vagal influence over neurotransmitter release has been implicated in the regulation of inflammation and immune cell activity
Here we are using a non-invasive vagus nerve stimulator to monitor changes in cognitive function and other symptoms in people with IDD both with and without ASD The device is FDA-approved for migraine and cluster headaches in people 12 years and older VNS activates the vagus nerve with mild electrical stimulation through the skin
Rather than embarking on a rigorously designed study we will conduct a series of single-subject studies that reflects each participants symptoms We will select the most appropriate dependent variables based on each persons symptom presentation
The vagus nerve strongly influences these autonomic functions including digestion breathing heart rate variability and metabolic function and central nervous system CNS activity that affect mood pain stress management sleep and even memory and cognitive functions The vagal influence over neurotransmitter release has been implicated in the regulation of inflammation and immune cell activity
Here we are using a non-invasive vagus nerve stimulator to monitor changes in cognitive function and other symptoms in people with IDD both with and without ASD The device is FDA-approved for migraine and cluster headaches in people 12 years and older VNS activates the vagus nerve with mild electrical stimulation through the skin
Rather than embarking on a rigorously designed study we will conduct a series of single-subject studies that reflects each participants symptoms We will select the most appropriate dependent variables based on each persons symptom presentation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None