SHARPEN - Parkinson's Disease Dementia

NCT05987540 | Terminated Results FDA Device

• 2 other identifiers: SNS-PD-0041R43NS132653-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease Dementia

Keywords

medical device; Non-Invasive Brain Stimulation; neuromodulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  12 weeks.

Study Arms (1)

Investigational Treatment

EXPERIMENTAL

Time-varying caloric vestibular stimulation

Device: Non-invasive brainstem stimulation

Interventions

Non-invasive brainstem stimulation DEVICE

Study participants will self-administer \~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.

Investigational Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scion NeuroStim: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Parkinson's Disease and Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Kansas Medical Center-Parkinson's Disease Center

Kansas City, Kansas, 66160, United States

Location

Limitations and Caveats

The Sponsor company was dissolved prior to completion of participant enrollment. This early termination limited the data analysis to the small number of participants that had completed, prevented completion of treatment adherence data collection from all study devices, and impacted final data close-out activities.

Results Point of Contact

• Title: Robert Black
• Organization: Scion NeuroStim, Inc

bacllc@earthlink.net

919-260-5528

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: May 8, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)