Trial Outcomes & Findings for SHARPEN - Parkinson's Disease Dementia (NCT NCT05987540)

Last Updated: 2025-05-09

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Treatment Time-varying caloric vestibular stimulation
Overall Study STARTED	9
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Treatment Time-varying caloric vestibular stimulation
Overall Study Withdrawal by Subject	2
Overall Study Death	1
Overall Study Study Termination	1
Overall Study Adverse Event	2

Baseline Characteristics

SHARPEN - Parkinson's Disease Dementia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Treatment n=9 Participants Time-varying caloric vestibular stimulation
Age, Continuous	75 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Montreal Cognitive Assessment (MoCA)	18 Total points n=5 Participants
MDS-UPDRS (Sum of Parts I, II, and III)	76 Total points n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Investigational Treatment n=5 Participants Time-varying caloric vestibular stimulation
MDS-UPDRS (Sum of Parts I, II & III)	-2 # of points difference Interval -7.0 to 17.0

PRIMARY outcome

Timeframe: 12 weeks

Population: Enrolled participants.

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 %

Outcome measures

Outcome measures
Measure	Investigational Treatment n=9 Participants Time-varying caloric vestibular stimulation
Feasibility of Neuromodulation Device Use in PDD Population, Part 1	3 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Treatment adherence rate during the 12-week treatment period. High adherence: \>84%, Moderate adherence: 55-84 %, Low adherence: \< 55 %

Outcome measures

Outcome measures
Measure	Investigational Treatment n=6 Participants Time-varying caloric vestibular stimulation
Feasibility of Neuromodulation Device Use in PDD Population, Part 2	95.4 percentage of treatment adherence Interval 10.0 to 100.0

SECONDARY outcome

Timeframe: 12 weeks.

Population: Participants that completed the MoCA at the End of Treatment visit (day 84) or early termination visit

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.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=5 Participants Time-varying caloric vestibular stimulation
Montreal Cognitive Assessment (MoCA)	0 # of points difference Interval -4.0 to 4.0

Adverse Events

Investigational Treatment

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Treatment n=9 participants at risk Time-varying caloric vestibular stimulation (tvCVS)
Infections and infestations COVID-19	22.2% 2/9 • Number of events 2 • 4 months, starting with consent. ct.gov definitions were used.
Infections and infestations Pneumonitis	11.1% 1/9 • Number of events 1 • 4 months, starting with consent. ct.gov definitions were used.

Other adverse events

Other adverse events
Measure	Investigational Treatment n=9 participants at risk Time-varying caloric vestibular stimulation (tvCVS)
Ear and labyrinth disorders Device Site Discomfort	44.4% 4/9 • Number of events 5 • 4 months, starting with consent. ct.gov definitions were used.
Injury, poisoning and procedural complications Fall	22.2% 2/9 • Number of events 3 • 4 months, starting with consent. ct.gov definitions were used.
Nervous system disorders Difficulty with return of objects	11.1% 1/9 • Number of events 1 • 4 months, starting with consent. ct.gov definitions were used.

Additional Information

Robert Black

Scion NeuroStim, Inc

Phone: 919-260-5528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place