Trial Outcomes & Findings for Vestibular Stimulation in Parkinson's Disease (NCT NCT02703844)

Results Overview

The NMSS is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. Score range of 0-360, with 0 being no symptom burden

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

Change at end of treatment (week 12) relative to the average of two baseline visits

Results posted on

2022-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Active Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 8 weeks, 7 days a week, twice daily for 19 minutes. Caloric Vestibular Stimulation: Stimulation of the vestibular nerves	Placebo Participants will be receiving a Sham Caloric Vestibular Stimulation treatment for a duration of 8 weeks in the same manner as the active arm: 7 days a week, twice daily for 19 minutes. Individuals allocated to this arm will be later crossed over, in unblinded fashion, to the active arm if the treatment shows evidence of efficacy and safety. Sham Caloric Vestibular Stimulation: Sham stimulation of the vestibular nerves
Randomized Controlled Portion STARTED	23	23
Randomized Controlled Portion COMPLETED	16	17
Randomized Controlled Portion NOT COMPLETED	7	6
Cross-Over to Active STARTED	0	14
Cross-Over to Active COMPLETED	0	5
Cross-Over to Active NOT COMPLETED	0	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=23 Participants Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 8 weeks, 7 days a week, twice daily for 19 minutes. Caloric Vestibular Stimulation: Stimulation of the vestibular nerves	Placebo n=23 Participants Participants will be receiving a Sham Caloric Vestibular Stimulation treatment for a duration of 8 weeks in the same manner as the active arm: 7 days a week, twice daily for 19 minutes. Individuals allocated to this arm will be later crossed over, in unblinded fashion, to the active arm if the treatment shows evidence of efficacy and safety. Sham Caloric Vestibular Stimulation: Sham stimulation of the vestibular nerves	Total n=46 Participants Total of all reporting groups
Age, Continuous	69.7 years STANDARD_DEVIATION 11.3 • n=23 Participants	72.2 years STANDARD_DEVIATION 6.6 • n=23 Participants	70.9 years STANDARD_DEVIATION 9.2 • n=46 Participants
Sex: Female, Male Female	11 Participants n=23 Participants	5 Participants n=23 Participants	16 Participants n=46 Participants
Sex: Female, Male Male	12 Participants n=23 Participants	18 Participants n=23 Participants	30 Participants n=46 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Non-Motor Symptom Scale (NMSS) Total Score	126.2 score on a scale STANDARD_DEVIATION 29.8 • n=23 Participants	117.7 score on a scale STANDARD_DEVIATION 32.6 • n=23 Participants	122 score on a scale STANDARD_DEVIATION 31.2 • n=46 Participants
MDS-UPDRS Part II Score	22.5 score on a scale STANDARD_DEVIATION 9.1 • n=23 Participants	21.4 score on a scale STANDARD_DEVIATION 5.3 • n=23 Participants	21.9 score on a scale STANDARD_DEVIATION 7.4 • n=46 Participants
MDS-UPDRS Part III Score	49.3 score on a scale STANDARD_DEVIATION 17.6 • n=23 Participants	45.4 score on a scale STANDARD_DEVIATION 16.3 • n=23 Participants	47.4 score on a scale STANDARD_DEVIATION 16.9 • n=46 Participants

PRIMARY outcome

Timeframe: Change at end of treatment (week 12) relative to the average of two baseline visits

Population: data reported for this outcome includes anyone who received at least one treatment with the study device and had a baseline NMSS performed. Change scores were not normally distributed and therefore nonparametric tests were used and medians are reported

The NMSS is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. Score range of 0-360, with 0 being no symptom burden

Outcome measures

Outcome measures
Measure	Active n=23 Participants Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 8 weeks, 7 days a week, twice daily for 19 minutes. Caloric Vestibular Stimulation: Stimulation of the vestibular nerves	Placebo n=23 Participants Participants will be receiving a Sham Caloric Vestibular Stimulation treatment for a duration of 8 weeks in the same manner as the active arm: 7 days a week, twice daily for 19 minutes. Individuals allocated to this arm will be later crossed over, in unblinded fashion, to the active arm if the treatment shows evidence of efficacy and safety. Sham Caloric Vestibular Stimulation: Sham stimulation of the vestibular nerves
Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)	-33.5 change in scale total score Interval -40.3 to -17.7	-2.0 change in scale total score Interval -16.5 to 8.3

SECONDARY outcome

Timeframe: Change at end of treatment (week 12) relative to baseline average

Population: data reported for this outcome includes anyone who received at least one treatment with the study device and had a baseline MDS-UPDRS Part II performed.

The MDS-UPDRS Part II is a 13-item patient-reported assessment of activities of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living

Outcome measures

Outcome measures
Measure	Active n=23 Participants Participants will be receiving an active Caloric Vestibular Stimulation treatment for a duration of 8 weeks, 7 days a week, twice daily for 19 minutes. Caloric Vestibular Stimulation: Stimulation of the vestibular nerves	Placebo n=23 Participants Participants will be receiving a Sham Caloric Vestibular Stimulation treatment for a duration of 8 weeks in the same manner as the active arm: 7 days a week, twice daily for 19 minutes. Individuals allocated to this arm will be later crossed over, in unblinded fashion, to the active arm if the treatment shows evidence of efficacy and safety. Sham Caloric Vestibular Stimulation: Sham stimulation of the vestibular nerves
Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living	-3.2 score on a scale Interval -5.1 to -1.2	-0.4 score on a scale Interval -1.7 to 1.0

SECONDARY outcome

Timeframe: Change at end of treatment (week 12) relative to baseline average

Population: data reported for this outcome includes anyone who received at least one treatment with the study device and had a baseline MDS-UPDRS Part III performed.

The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Scores range between 0-132 with higher scores indicating more severe motor symptoms