Clinical trial NCT04652583: Auricular Muscle Zone Stimulation for Parkinson Disease
Official title: Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Stoparkinson Healthcare Systems LLC
Sponsor class: INDUSTRY
Collaborators: name: The Parkinson Study Group
First posted: 2020-12-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Blinded, Electronic Device in Subjects with Parkison Disease.

Detailed description: This study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with Parkinson's Disease who have the wearing-off phenomenon on oral levodopa therapy. All participants will receive three treatments on different days, each with different stimulation conditions. All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinson's Disease for 120 minutes during each of the three treatment applications.

Eligibility criteria: Inclusion Criteria:

1. Subject is a male or female ≥18 years of age.
2. Subject has Parkinson's Disease and is on levodopa therapy.
3. Subject experiences OFF periods with an "ON" score ≥20% better than the OFF score as measured by the MDS-UPDRS motor score (MDS-UPDRS Part III).
4. The subject's daily "OFF" time duration is ≥2 hours per day.
5. The subject's Hoehn-Yahr stage when "OFF" must be less than Stage 4 (i.e., subject must be able to walk without the use of an assisted device, such as a cane or a walker).
6. Subject receives levodopa at least TID with a minimum of 100 mg levodopa administered with each dose.
7. Subject can tolerate 2 hours in an "OFF" period without requiring rescue medication.
8. Subject is willing and able to not change Parkinson's Disease medications or dosages during the up to 2 week study therapy period.
9. Subject is willing to provide Informed Consent to participate in the study.
10. Subject is willing and able to comply with all study procedures and required availability for study visits.

Exclusion Criteria:

1. Subject has a medical or psychiatric comorbidity that can compromise participation in the study.
2. Subject has cognitive dysfunction defined by a Montreal Cognitive Assessment (MoCA) score \<24.
3. Subject has moderate levodopa-induced dyskinesias as indicated by a score \>2 on items 4.1 and/or 4.2 in the MDS-UPDRS Part IV.
4. Subject has clinically significant depression as determined by the Beck Depression Inventory-II score \>15.
5. Subject is pregnant as determined by a urine pregnancy test at the screening visit.
6. Subject is of childbearing potential and is not surgically sterilized or does not use a reliable measure of contraception.
7. Subject has a form of Parkinsonism other than Parkinson's Disease, such as Drug-induced Parkinsonism or Multiple System Atrophy.
8. Subject has an implanted deep brain stimulator (DBS).
9. Subject is receiving direct intestinal infusions of levodopa.
10. Subject has epilepsy.
11. Subject medications are anticipated to change during the two (2) week study period (Note: the study requires stable medications during the device testing period).
12. Subject has a cardiac pacemaker or defibrillator, bladder stimulator, spinal cord stimulator or other active electronic medical device.

Primary outcomes:
measure: Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Score) at 20 minutes
timeFrame: Baseline, 20 minutes after the stimulation is initiated
Secondary outcomes:
measure: Area Under Curve
timeFrame: 120 minutes after stimulation is initiated.
measure: Maximal improvement in MDS-UPDRS motor score (MDS-UPDRS Part III) from prior to stimulation to any of the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Patient Global Impression of Change (PGIC) scored by the subject prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Timed Get Up and Go test prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Clinical Global Impression of Change (CGIC) prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: Baseline, 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Finger Tapping Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Rest Tremor Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores comparison between each study arm at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Postural Tremor Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Finger Tapping Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Hand Grasp Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Hand Grasp Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Kinesia-ONE™ Variable: Dyskinesia Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Determination by the investigator of dyskinesia severity by MDS-UPDRS Part IV prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated
measure: Determination by a consensus between subject and investigator of whether the subject is "OFF" or "ON" prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Change in mood as measured by the Depressed Mood Score from baseline to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Change in mood as measured by the Anxiety Mood Score from baseline to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
measure: Change in subjects' sense of well-being as measured by an exploratory ordinal scale prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.
timeFrame: 120 minutes after stimulation is initiated.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorder's Center, PC
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson Disease and Movement Disorder Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
Study officials:
affiliation: Stoparkinson Healthcare Systems LLC
name: Yusuf O Cakmak, MD, PhD
role: STUDY_DIRECTOR
affiliation: H. Houston Merritt Professor of Neurology, Columbia University Medical Center
name: Stanley Fahn, MD
role: PRINCIPAL_INVESTIGATOR
References: