SHARPEN - Parkinson's Disease Dementia (SHARPEN)

Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia

The purpose of this single arm study is to evaluate the feasibility and safety of treatments with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that stays outside of the body and is not implanted and does not penetrate the skin.

Neuromodulation means that the device stimulates activity in the brain.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease Dementia
• Intervention / Treatment: Device: Non-invasive brainstem stimulation

Detailed Description

Up to 12 participants will self-administer treatments twice daily in the home setting over a period of 12 weeks. There are 4 study center visits, including an eligibility visit, as well as multiple phone calls.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease And Movement Disorder Center Of Boca Raton
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center-Parkinson's Disease Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults, age 50 years of older, diagnosed with Clinically Established or Clinically Probable Parkinson's disease according to the MDS Clinical Diagnostic Criteria
• Participants with a clinical diagnosis of probable Parkinson's disease dementia ( PDD) using criteria defined in Emre et al., 2007 and in accordance with procedures defined in Dubois et al., 2007 (allowing for diagnosis of PD defined in Step 1 to be according to MDS Clinical Diagnostic criteria instead of the Queen Square Brain Bank Criteria)
• Participants must be able and willing to consent to participate in the study and comply with all study requirements. If the participant is unable to consent due to limited capacity, a Legally Authorized Representative (LAR) must consent.
• Participants and investigators must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD and not to introduce new medications used to treat PD (motor or non-motor symptoms) during the study.
• The principal investigator, or designee, must have confidence in the participant's ability to reliably use the TNM™ device, and to understand and complete the assessments (provided in English only) within a given on-state.
• Participant must have a study partner (defined as someone who sees the participant for more than three hours a day, 5 times per week) that is willing to consent and participate in the trial.

Exclusion Criteria:

• Participant anticipates being unable to attend all visits and complete all study activities during the trial.
• Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the trial
• Has any significant co-morbidity/condition, planned surgery or participation in another clinical trial which may either prevent safe participation in the study procedures or interfere with the evaluation of safety or efficacy of the study Device as a potential treatment for PDD
• In the Investigator's opinion, has severe dementia, (e.g., Mini Mental State Exam score (at screen visit) <15 and/or requires significant assistance with activities of daily living due to cognitive deficits)
• Has experienced a myocardial infarction, angina, or stroke within the past 12 months, transient ischemic attack (TIA) within the past 6 months or has a documented aspiration event in the medical records
• Are receiving late-stage therapies for PD (e.g., deep brain stimulation or pump infusion therapies) or are being treated with another neurostimulation device
• History of interventional brain surgery or have received magnetic resonance guided high intensity focused ultrasound
• Demonstrate suicidality at screening (scores ≥ 4 on the Columbia- Suicide Severity Rating Scale Baseline "In the past Month" section)
• Have been previously diagnosed with either clinically meaningful central vestibular dysfunction (lifetime) or have experienced clinically meaningful peripheral vestibular dysfunction within the last 12 months
• Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination
• Use any drugs excluded in the Excluded Medications List
• Use of antipsychotic medication(s) listed in the Approved Concomitant Medications (i.e., pimavanserin and quetiapine) that have not been taken for more than 180 days and does not have medical record documentation of normal QTc interval (i.e., no prolongation of the QTc interval) as measured via electrocardiogram after starting the medication
• Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination performed by medically qualified Investigators or have chronic tinnitus that has been ongoing for at least 3 months
• Have a cochlear implant, myringotomy tubes or hearing aids that cannot be easily/reliably removed for treatment
• Clinically significant abnormalities in B12, thyroid function, blood count, comprehensive metabolic panel or urinalysis results tested at the study screen. Screening tests are not required in cases where test results within normal range within 6 months of study screen are documented in the medical records.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Treatment; Time-varying caloric vestibular stimulation	Device: Non-invasive brainstem stimulation; Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MDS-UPDRS (Sum of Parts I, II & III)	Parts I, II, and III of the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor (Parts I and III) and non-motor (Part II) experiences and complications of Parkinson's disease (PD) by which it characterizes the extent and burden of disease. Questions/evaluations are divided across Part I (13 questions, 52 possible points), Part II (13 questions, 52 possible points), Part III (33 questions based on 18 items, several with right, left or other body distribution scores, 132 possible points) and summed. Each question has five response options linked to accepted clinical terms (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe) for a total possible score of 236. The change between baseline and Day 84 is reported. A positive change in scores between baseline to Day 84 indicates symptom/disease worsening. A negative change in score between baseline and Day 84 indicates symptom/disease improvement.	12 weeks
Feasibility of Neuromodulation Device Use in PDD Population, Part 1	Retention rate or the percent of participants that complete the secondary endpoint (MoCA) at all study visits in the study protocol during the 12-week treatment period. High retention: >90%, Moderate retention: 60-90 %, Low retention:< 60 %	12 weeks
Feasibility of Neuromodulation Device Use in PDD Population, Part 2	Treatment adherence rate during the 12-week treatment period. High adherence: >84%, Moderate adherence: 55-84 %, Low adherence: < 55 %	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	The MoCA assesses cognition over 6 domains: Memory, Executive function, Attention, Language, Visuospatial, and Orientation. Points across all 6 domains are summed, and this sum equals the total score (min 0 - max 30). A higher total score indicates better cognitive function; a positive score for difference in points indicates improvement. A total score of 26-30 reflects normal cognition. Mild cognitive impairment is associated with a total score of 18-25. Total scores of 10 - 17 indicate moderate cognitive impairment; a total score less than 10 shows severe cognitive impairment. The change (difference) in the Montreal Cognitive Assessment (MoCA) total score taken at baseline and, again, at the end of treatment visit (Day 84) after 12 weeks of treatment is reported. A positive change in scores indicates improvement; whereas, a negative change in scores between baseline and Day 84 indicates worsening.	12 weeks.

Collaborators and Investigators

• Sponsor: Scion NeuroStim
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: medical device; neuromodulation; Non-Invasive Brain Stimulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Dementia
• Other Study ID Numbers: SNS-PD-004; 1R43NS132653-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No