# Simple, Home-use, neurostimulAtion tReatment for Parkinson's disease dEmeNtia (SHARPEN)

> **NIH NIH R43** · SCION NEUROSTIM, LLC · 2024 · $327,682

## Abstract

PROJECT SUMMARY
Parkinson’s disease dementia (PDD) is a frequent non-motor symptom in patients with Parkinson’s disease (PD).
PDD is associated with cognitive decline that can increase morbidity and mortality and dramatically reduce
patient quality of life. Three out of four PD patients will develop PDD, yet the only FDA-approved treatment for
PDD is rivastigmine which provides effects that are short-lived and modest at best and may worsen PD motor
symptoms. Furthermore, gold standard therapies for Parkinsonian motor impairments (i.e., levodopa and deep
brain stimulation) can worsen PDD, yet stopping treatment is typically not recommended. To address this dire
need, Scion NeuroStim, Inc has developed a novel, home-use device that non-invasively stimulates nuclei in the
brainstem that send projections throughout the brain to regulate a variety of functions including cognition,
memory, well-being, and mood. In a previous double-blind, randomized controlled trial, eight weeks of Device
treatments dramatically improved both motor and non-motor symptoms in PD patients. Device treatments were
well tolerated and safe with only infrequent, transient, and mild side effects. Importantly, a sub-analysis of data
from participants with evidence of either mild cognitive impairment or dementia revealed that Device treatment
was associated with significantly improved cognitive performance according to the Montreal Cognitive
Assessment. Treatment adherence was excellent and study participants remained blind to their treatment
allocation. Furthermore, the kinetics of the clinical responses indicate that longer treatment periods are likely to
result in even greater clinical improvements. Thus, in this project, Scion will conduct a single-arm clinical trial to
evaluate the safety and feasibility of non-invasive brainstem stimulation with Scion’s Device over a period of 12
weeks in PDD patients. Further, it will explore the potential for Scion’s Device to treat cognitive and other motor
and non-motor symptoms associated with PDD, which, if favorable, will enable the design and powering of a
pivotal trial.

## Key facts

- **NIH application ID:** 10886725
- **Project number:** 5R43NS132653-02
- **Recipient organization:** SCION NEUROSTIM, LLC
- **Principal Investigator:** Kristen Kathleen Foster
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $327,682
- **Award type:** 5
- **Project period:** 2023-07-15 → 2025-04-02

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10886725

## Citation

> US National Institutes of Health, RePORTER application 10886725, Simple, Home-use, neurostimulAtion tReatment for Parkinson's disease dEmeNtia (SHARPEN) (5R43NS132653-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10886725. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*