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Neuromodulation System for Alcoholism
N/A
Recruiting
Led By KT Venkateswara-Rao, PhD
Research Sponsored by Theranova, L.L.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study Summary
This trial was carefully designed to test a medical treatment, comparing it to a "dummy" treatment.
Who is the study for?
Adults over 21 with alcohol use disorder, drinking at moderate to very high risk levels, who want to reduce or quit alcohol. They must be sober during enrollment and women of childbearing age need a negative pregnancy test. Excluded are those needing medical detox, with recent changes in addiction therapy, metal implants interfering with the device, unstable psychiatric disorders, neurodegenerative diseases, other substance disorders (except nicotine/cannabis), pregnant/breastfeeding women or those not using birth control.Check my eligibility
What is being tested?
The trial is testing the Empower Neuromodulation System on people with alcoholism. It's conducted across multiple sites where participants are randomly assigned to receive either the actual neuromodulation treatment or a sham (fake) treatment without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed for this neuromodulation system, similar treatments can cause skin irritation at electrode sites, discomfort from electrical stimulation and potential headaches or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint: Change in WHO risk level via 28-day TLFB
Primary Safety Endpoint: Frequency of device-related Serious AEs (SAEs)
Secondary outcome measures
Change in Alcohol Consumption via PEth analysis
Change in Alcohol Craving Intensity via daily self reports
Change in Alcohol Craving Intensity via the Penn Alcohol Craving Survey (PACS)
+3 moreOther outcome measures
Exploratory Effectiveness - % Drink change Week 12 via App
Exploratory Effectiveness - % Drink change Week 12 via TLFB
Exploratory Effectiveness - Abstinence at Week 12 via TLFB
+16 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active TreatmentActive Control1 Intervention
The Active Treatment will use a functional Stimulator system.
Group II: Sham TreatmentPlacebo Group1 Intervention
The Sham Treatment (Placebo) will use a functional Stimulator system, but will provide a treatment in a location that is believed to have no benefit or harm to the subject.
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Who is running the clinical trial?
Theranova, L.L.C.Lead Sponsor
11 Previous Clinical Trials
341 Total Patients Enrolled
2 Trials studying Alcoholism
42 Patients Enrolled for Alcoholism
KT Venkateswara-Rao, PhDPrincipal InvestigatorTheraNova, LLC
David Pennington, PhDPrincipal InvestigatorNorthern California Institute of Research and Education
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience numbness or tingling in my arm at least once a week.I have been diagnosed with a neurodegenerative disease like Parkinson's, dementia, or Alzheimer's.I am currently pregnant, breastfeeding, have been pregnant in the last 6 months, plan to become pregnant, or won't use birth control during the study.I am 21 years old or older.I am taking or will start taking medication for alcohol use disorder.I have had acupuncture or acupressure in my arms in the last 3 months.I have used a TENS unit on my arms in the last 3 months.I am willing and able to follow all the study's requirements.I have a history of epilepsy or seizures.I have changed my alcohol use disorder medication in the last 4 weeks.I have an open wound or infection where the Empower device would be placed.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment
- Group 2: Sham Treatment
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 this research currently accepting new participants?
"Unfortunately, this clinical trial is not presently enrolling participants. Initially posted on August 1st of 2023 and last updated a few days ago, the study has currently paused recruitment efforts. Fortunately there are still 387 other studies actively recruiting patients at present."
Answered by AI
What is the primary focus of this experiment?
"This clinical study aims to measure the efficacy of a treatment by comparing WHO risk levels, heavy drinking days (HDD), alcohol-related problems via SIP, and phosphatidylethanol (PEth)-based evaluation of alcohol consumption at Week 12 between Active and Sham Treatment groups. HDD is defined as 5 or more drinks for men and 4 or more drinks for women in one calendar day."
Answered by AI
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