# XCSITE 300: Cloud-Enabled Closed-Loop Transcranial Current Stimulation Device for At-Home Studies

> **NIH NIH R44** · PULVINAR NEURO LLC · 2024 · $1,161,624

## Abstract

PROJECT SUMMARY – Pulvinar Neuro LLC, TOWNSEND
The causal role of circuit activity dynamics in depression remains poorly understood due to the lack of tools for
non-invasive, targeted circuit modulation. Today’s non-invasive brain stimulation approaches apply generic
stimulation waveforms without targeting individual activity signatures and without dynamically adapting
stimulation to ongoing fluctuations in brain activity. To address this gap, the long-term goal of Pulvinar Neuro is
to develop, evaluate, and commercialize targeted closed-loop transcranial alternating current stimulation (tACS)
technology, which measures brain activity with EEG and dynamically applies weak rhythmic electric fields to
modulate network oscillations. In the previous Phase 1 SBIR, Pulvinar Neuro developed XCSITE 100Pro, a
closed-loop tACS device that was successfully tested for feasibility in healthy human participants, and XCSITE
200, a cloud-based platform for remote stimulation. The overall goal of this application is to develop and evaluate
the XCSITE 300 platform that will integrate closed-loop capabilities with cloud-based stimulation and study
management. The rationale for this project is that such a solution will drive the next generation of circuit-based
research in psychiatry and that closed-loop tACS has the potential to become a safe and effective treatment for
depression given the initial positive findings of open-loop tACS for the treatment of depression and the substantial
unmet market need. Three specific aims will be pursued to accomplish this goal. (1) Integrate and bench test
closed-loop tACS technology with cloud-based infrastructure, (2) Test XCSITE 300 for in-lab use in a pilot
double-blind single-site study for the treatment of depression (XCSITE 300 Clinic), and (3) Adapt device form
factor and user interface for at-home use (XCSITE 300 Home) and establish feasibility in a pilot study in people
with depression. At completion of the proposed work, feasibility and preliminary efficacy of closed-loop tACS will
be established and closed-loop tACS for use in a clinic and for at-home use by patients will be ready for pivotal
studies for the treatment of depression. The work in this application is innovative given the lack of available
cloud-enabled (“smart”) closed-loop tACS devices for probing circuit dynamics and for evaluation of clinical
efficacy in rigorous double-blind trials. The proposed work is significant since closed-loop tACS will enable the
investigation of the causal role of specific circuit dynamics in humans and the development of novel treatments
for depression which are urgently needed.

## Key facts

- **NIH application ID:** 10813862
- **Project number:** 5R44MH119872-04
- **Recipient organization:** PULVINAR NEURO LLC
- **Principal Investigator:** Leah Bishop Townsend
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,161,624
- **Award type:** 5
- **Project period:** 2019-09-11 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10813862

## Citation

> US National Institutes of Health, RePORTER application 10813862, XCSITE 300: Cloud-Enabled Closed-Loop Transcranial Current Stimulation Device for At-Home Studies (5R44MH119872-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10813862. Licensed CC0.

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