NCT04106739

A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear

Completed NA Last updated 3 March 2022

What this trial tests

NA trial testing Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS) in Alcohol Use Disorder in 44 participants. Completed in 27 December 2021.

Timeline

20 October 2019

Primary endpoint
27 December 2021

27 December 2021

Quick facts

Lead sponsor	DyAnsys, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	20 October 2019
Primary completion	27 December 2021
Estimated completion	27 December 2021
Sites	1 location across India

Drugs / interventions tested

• Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

DyAnsys, Inc.

Who can join

Adults 18 to 50, male only, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with relapse. Keeping in mind the high burden of disease due to AUD, limited efficacy of available treatment modalities it is important to study new treatment modalities. Vagus nerve stimulation (VNS) is a promising neuromodulation technique with robust evidence in epilepsy and treatment-resistant depression. fMRI studies show that transcutaneous VNS (tVNS) replicates most of the biological effects of VNS with an additional advantage of being non-invasive. Percutaneous Electrical Neural Field Stimulation (PENFS) of auricular branch of vagus nerve is a variant of tVNS which has shown promise in the treatment of opioid withdrawal. The efficacy of PENFS has been evaluated in AUDs in only handful of studies.

I propose to employ a double-blind randomized sham-controlled trial where 40 subjects with AUD will be randomized to 2 groups, with 1 group receiving 'Active' auricular PENFS, and another group receiving bilateral 'sham' auricular PENFS.

Assessments will be carried out at baseline and after 15 days of advent of PENFS on tasks to assess craving, along with neurohemodynamic changes on functional Magnetic Resonance Image (fMRI). Follow up of patients will be done till the first relapse or till 3 months after the post evaluation, whichever is earlier.

The investigator's hypotheses are:

1. Active PENFS will lead to significantly greater improvement in subjective craving and drinking-related outcomes as compared to sham PENFS in patients with AUD over the follow-up period of 3 months.
2. Active PENFS will produce a significantly differential Blood Oxygen Level Dependent (BOLD) activation-deactivation pattern of brain regions (greater activation of dorsolateral prefrontal cortex and anterior cingulate cortex and along with deactivation of insular cortex) associated with craving during a cue-induction paradigm as compared to sham PENFS in patients with AUD.
3. Active PENFS will result in a significant differential change in resting-state functional connectivity (fMRI measured) within and between addiction-related neural networks as compared to sham PENFS as evaluated with a resting state fMRI analysis in patients with AUD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Involvement of the Dorsal Vagal Complex in Alcohol-Related Behaviors.
   Keller BN, Hajnal A, Browning KN, Arnold AC, et al · · 2022 · cited 14× · PMID 35330845 · DOI 10.3389/fnbeh.2022.801825