# Development and Evaluation of a Higher Power tACS Device for the Treatment of SUD

> **NIH NIH R43** · PULVINAR NEURO LLC · 2022 · $55,000

## Abstract

PROJECT SUMMARY – Pulvinar Neuro LLC, TOWNSEND
Substance use disorder (SUD) is a highly prevalent but difficult to treat brain disorder (Wise et al., 2014;
McLellan et al., 2000). While clinicians have a range of a range of pharmacologic and behavioral interventions
available for the treatment of SUD, unmet need remains high regardless of drug of abuse with 12-month
relapse rates of 40-60% (Klein, 2016; McLellan et al., 2000). Transcranial alternating current stimulation
(tACS) represents a novel therapeutic approach for the treatment of SUD with a recent study of tACS in SUD
showing promising initial results (Daughters et al., 2020). However, shifting from short-term, instantaneous
effects of stimulation to long-lasting, therapeutic circuit modulation requires more extensive tACS paradigms
than can currently be achieved with existing technology.
In the predicate Phase I SBIR project, we address this gap by developing XCSITE HPtACS, a high-powered
tACS device based on our existing XCSITE platform that enables gold-standard, double-blind, placebo-
controlled study designs. In this project, we will complete modifications to our existing XCSITE 100 device to
enable the higher amplitude stimulation required for a durable therapeutic effect. We will evaluate the
performance and safety of the device in a preclinical rat study before evaluating feasibility and tolerability of
higher amplitude stimulation in a pilot study of patients with SUD. The goal of the predicate Phase 1 grant is
to advance product development and testing to prepare the device for further clinical development ahead of
seeking FDA clearance for the treatment of SUD. Pulvinar Neuro has successful track-record of developing
and commercializing mobile neurophysiology research equipment. In a future Phase 2 study, we plan to
perform an initial treatment clinical trial to assess the efficacy of XCSITE HPtACS as a therapeutic for SUD.

## Key facts

- **NIH application ID:** 10541305
- **Project number:** 3R43DA054848-01S1
- **Recipient organization:** PULVINAR NEURO LLC
- **Principal Investigator:** Leah Bishop Townsend
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2021-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10541305

## Citation

> US National Institutes of Health, RePORTER application 10541305, Development and Evaluation of a Higher Power tACS Device for the Treatment of SUD (3R43DA054848-01S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10541305. Licensed CC0.

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