tAN for Substance Use Disorder

Summary

The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.

Conditions

• Alcohol Use Disorder
• Alcohol Abuse
• Substance Use Disorders
• Substance Use Disorders Alcohol Use Withdrawal State

Interventions

DEVICE

Sparrow Ascent

The Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece.

DEVICE

Sparrow Ascent (Sham)

Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device.

Sponsors & Collaborators

• The Menninger Clinic

  collaborator UNKNOWN

• Baylor College of Medicine

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Spark Biomedical, Inc.

  lead INDUSTRY

Principal Investigators

• Navid Khodaparast, PhD · Spark Biomedical, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-28

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations