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Nerve Stimulation
Vagus Nerve Stimulation for Alcohol Withdrawal
N/A
Waitlist Available
Led By Andrew C Chen, MD, PhD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
age 18-65 years (men and women);
being admitted to inpatient detoxification unit;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after completion of pilot study (enrollment)
Awards & highlights
Study Summary
This trial will test if stimulating the vagus nerve can help patients with alcohol use disorder who are going through withdrawal.
Who is the study for?
This trial is for adults aged 18-65 with alcohol use disorder entering detox, who can understand the study and agree to participate. They must have a clear enough mental state (MMSE score >22) and not be pregnant or have severe medical conditions like liver issues, seizures from drinking, serious psychiatric illnesses, or cognitive impairments.Check my eligibility
What is being tested?
The study tests if non-invasive vagus nerve stimulation behind the ear can ease withdrawal symptoms in patients stopping alcohol use. Participants will receive either real nerve stimulation or a sham (fake) treatment to compare effectiveness during detoxification.See study design
What are the potential side effects?
Potential side effects are not specified but may include discomfort at the site of stimulation. Since it's non-invasive and doesn't involve drugs, fewer side effects are expected compared to medication-based treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I am currently admitted to an inpatient detoxification unit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after completion of pilot study (enrollment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after completion of pilot study (enrollment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary clinical outcome is the reduction of the alcohol withdrawal symptoms assessed by the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
Other outcome measures
Assesssment of change of neruroinflammatory reflex by measurement of blood levels of cytokines following VNS treatment for acute alcohol withdrawal
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VNS transcutaneous stimulationExperimental Treatment1 Intervention
5 minutes of stimulation (VNS) twice a day for 4 days. Patients will receive transcutaneous stimulation (30 Hz, 300 msec.) on the auricular branch of the vagus nerve 5 minutes twice a day for 4 days. Due to the theoretical risk that right vagus nerve stimulation could affect the heart, and to ensure consistency of the intervention, all subjects randomized to receive transcutaneous vagus nerve stimulation will receive stimulation of the auricular branch of the left vagus nerve. The subject will be blinded to their treatment arm.
The device to be used will include a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve, which innervates the skin of a specific ear area termed "Cymba Concha". Electrodes will be placed on this area to provide stimulation to the auricular branch of the afferent vagus nerve.
Group II: Sham stimulationPlacebo Group1 Intervention
5 minutes of sham stimulation (no electrical stimulation) twice a day for 4 days Patients will receive sham stimulation on the auricular branch of the vagus nerve 5 minutes twice a day for 4 days.
The subject will be blinded to their treatment arm. The specific target at the ear will be the auricular branch of the vagus nerve, which innervates the skin of a specific ear area termed "Cymba Concha". Electrodes will be placed on this area to provide sham stimulation (no electrical current) to the auricular branch of the afferent vagus nerve.
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,933 Total Patients Enrolled
Andrew C Chen, MD, PhDPrincipal InvestigatorNorthwell Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a substance use disorder, except for tobacco, cannabis, or alcohol.You have severe mental health conditions like bipolar disorder or psychotic disorders.You have a history of seizures or significant medical issues related to alcohol consumption.I am between 18 and 65 years old.You have a pacemaker, defibrillator, hearing aid, cochlear implant, or deep brain stimulator implanted in your body.I am taking medication that affects my bladder or saliva production.I do not have severe illnesses like liver problems or confusion spells.I am currently admitted to an inpatient detoxification unit.I have severe thinking or memory problems due to a condition like dementia.
Research Study Groups:
This trial has the following groups:- Group 1: VNS transcutaneous stimulation
- Group 2: Sham stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the participant age range for this trial extending beyond eighty years?
"This experiment has an age restriction of 18 to 65. Separately, there are 20 trials targeted at minors and 201 specifically for individuals over the retirement age."
Answered by AI
Are there any vacant positions available for participants in this experiment?
"Clinicialtrials.gov indicates that this particular trial is not actively seeking participants at the moment, despite first being posted on February 28th 2023 and last edited October 18th 2022. Nonetheless, there are still 270 other trials recruiting patients currently."
Answered by AI
Am I eligible to participate in this investigation?
"This clinical trial is recruiting 70 individuals aged 18-65 with a diagnosis of alcoholism. All participants must have an MMSE score greater than 22 and be admitted to inpatient detoxification unit."
Answered by AI
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