Parkinson Disease DementiaSHARPENNCT05987540

SHARPEN - Parkinson's Disease Dementia

A study testing Non-invasive brainstem stimulation in people with Parkinson Disease Dementia, run by Scion NeuroStim at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Parkinson Disease Dementia
What is being tested?: Non-invasive brainstem stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesUnited States
Study dates: 8 May 2024to 24 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 15Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, 33486
University of Kansas Medical Center-Parkinson's Disease Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

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

Neuromodulation means that the device stimulates activity in the brain.

Read the 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.

Conditions: Parkinson Disease Dementia
Being tested: Non-invasive brainstem stimulation
Keywords: medical device, Non-Invasive Brain Stimulation, neuromodulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05987540
Study group	Role	What they receive
Investigational Treatment	Experimental	Time-varying caloric vestibular stimulation Receives: Device: Non-invasive brainstem stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 %
Measured: 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 %
Measured: 12 weeks

Secondary outcomes (1)

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.
Measured: 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202424 Feb 2025

First posted14 Aug 2023
Study start8 May 2024
Primary completion24 Feb 2025
Study completion24 Feb 2025

Why it stopped: Company closure

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson Disease DementiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05987540
Sponsor's protocol ID: SNS-PD-004
Other IDs: 1R43NS132653-01
Acronym: SHARPEN
Status last verified: Apr 2025
First submitted: 26 Jul 2023
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)

All Parkinson Disease Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia
ClinicalTrials.gov ID: NCT05987540
Acronym / sponsor ID: SHARPEN / SNS-PD-004
Conditions: Parkinson Disease Dementia
Keywords: medical device, Non-Invasive Brain Stimulation, neuromodulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company closure
Enrolment: 9 participants (actual)
Lead sponsor: Scion NeuroStimIndustry (pharma, biotech, devices)
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 8 May 2024 (actual)
Primary completion: 24 Feb 2025 (actual)
Study completion: 24 Feb 2025 (actual)
First posted: 14 Aug 2023 (actual)
Results: Posted 9 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Neuromodulation means that the device stimulates activity in the brain.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigational Treatment	Experimental	Device: Non-invasive brainstem stimulationTime-varying caloric vestibular stimulation

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-invasive brainstem stimulationStudy participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.	Device	Investigational Treatment

Primary outcome

MDS-UPDRS (Sum of Parts I, II & III)
Time frame: 12 weeks
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.
Feasibility of Neuromodulation Device Use in PDD Population, Part 1
Time frame: 12 weeks
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 %
Feasibility of Neuromodulation Device Use in PDD Population, Part 2
Time frame: 12 weeks
Treatment adherence rate during the 12-week treatment period. High adherence: >84%, Moderate adherence: 55-84 %, Low adherence: < 55 %

1 secondary outcome

Montreal Cognitive Assessment (MoCA)
Time frame: 12 weeks.

Results and safety

Results posted to the registry on 9 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Treatment	9	3

Primary outcome: MDS-UPDRS (Sum of Parts I, II & III)

Time frame: 12 weeks. Median (Full Range). Unit: # of points difference

Measure	Investigational Treatment n = 5
Value	-2 (-7 to 17)

Investigational Treatment: p = .8125, Wilcoxon matched-pairs signed rank

Population analysed: Participants that completed an end of treatment visit or early termination visit.

Primary outcome: Feasibility of Neuromodulation Device Use in PDD Population, Part 1

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Investigational Treatment n = 9
Value	3

Population analysed: Enrolled participants.

Primary outcome: Feasibility of Neuromodulation Device Use in PDD Population, Part 2

Time frame: 12 weeks. Median (Full Range). Unit: percentage of treatment adherence

Measure	Investigational Treatment n = 6
Value	95.4 (10 to 100)

Population analysed: Participants for whom study devices that had been received by the Sponsor prior to study termination allowing for study device data download.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 months, starting with consent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Treatment	2 of 9 (22.2%)	4 of 9 (44.4%)	1 of 9

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Parkinson Disease Dementia

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
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RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive brainstem stimulation in people with Parkinson Disease Dementia, run by Scion NeuroStim at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MDS-UPDRS (Sum of Parts I, II & III) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05987540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.