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Vagus Nerve Stimulation (VNS) for Intellectual Disability (VNS Trial)

N/A

Recruiting

Led By Helen Yoo, Ph.D.

Research Sponsored by New York State Institute for Basic Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 4 weeks for 3, 4, or 5 months

Awards & highlights

VNS Trial Summary

"This trial aims to study the effects of vagus nerve stimulation (VNS) on behavior, cognition, and biorhythms in children and adults with autism and developmental disabilities. The main goals are

Who is the study for?

This trial is for children and adults with autism or developmental disabilities. Participants will choose to receive daily Vagus Nerve Stimulation (VNS) treatment for 1, 2, or 3 months and attend monthly study visits. Specific eligibility criteria are not provided.Check my eligibility

What is being tested?

The study tests the effects of VNS on behavior, cognition, and biological rhythms in participants with autism and developmental disorders. It aims to identify who might benefit from VNS and observe how it influences a range of symptoms.See study design

What are the potential side effects?

Potential side effects of VNS may include voice changes, coughing, throat pain or tingling, difficulty swallowing, shortness of breath during exercise, or skin irritation where the device is placed.

VNS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks for 3, 4, or 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 4 weeks for 3, 4, or 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks for 3, 4, or 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aberrant Behavior Checklist-Community (ABC-C)

Behavior Rating Inventory of Executive Function (BRIEF)

Pervasive Developmental Disorder Behavior Inventory (PDDBI)

+3 more

Secondary outcome measures

Biorhythmic motion measurements

Electro-encephalogram (EEG)

Neurocognitive assessment

Other outcome measures

Clinical Global Impression Scale Severity & Improvement (CGI-S, CGI-I)

Columbia-Suicide Severity Rating Scale (C-SSRS)

Non-verbal Pain Measure

VNS Trial Design

1Treatment groups

Experimental Treatment

Group I: Vagus Nerve Stimulation (VNS)Experimental Treatment1 Intervention

Single-subject design: ABA, ABBA, or ABBBA This study allows for a flexibility in the duration of research participation depending on one's response. The participant will be able to select one of the three design options (1, 2, or 3 months of VNS twice per day) in consultation with the study staff. That is, after the initial 1-month trial of VNS, the participant may choose to extend the VNS two more times (i.e., 1 or 2 months), for a total of 90 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vagus Nerve Stimulation

2019

N/A

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New York State Institute for Basic ResearchLead Sponsor

6 Previous Clinical Trials

889 Total Patients Enrolled

Rutgers UniversityOTHER

113 Previous Clinical Trials

2,804,018 Total Patients Enrolled

Boston Children's HospitalOTHER

761 Previous Clinical Trials

5,579,855 Total Patients Enrolled

7 Trials studying Intellectual Disability

103,853 Patients Enrolled for Intellectual Disability

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria for participation in this experimental endeavor?

"Individuals eligible for enrollment in this research study must possess a diagnosis of autism spectrum disorder and be aged between 12 to 40 years. The trial has availability for up to 75 participants."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Correct. The details available on clinicaltrials.gov indicate that this investigation is actively seeking participants. Initially shared on March 1, 2024, the trial was last revised on February 6, 2024. Enrollment aims to reach a total of 75 patients distributed across two locations."

Answered by AI

Is the recruitment for this clinical trial limited to individuals who are 45 years of age or older?

"Participants eligible for this research study must fall between the ages of 12 and 40. Among clinical trials, there are a total of 271 studies focusing on individuals under 18 years old and 68 targeting those above 65."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"Affirmative. The details on clinicaltrials.gov indicate that this investigation is presently enrolling volunteers. It was initially published on March 1, 2024, and most recently revised on February 6, 2024. The research aims to enlist a total of 75 participants distributed among two designated sites."

Answered by AI