NCT04652583

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started May 2021

Shorter than P25 for phase_2 parkinson-disease

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

November 10, 2020

Last Update Submit

January 7, 2022

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Score) at 20 minutes

    The primary efficacy endpoint is the overall change from baseline to 20 minutes after onset of stimulation in MDS-UPDRS motor score (MDS-UPDRS Part III), comparing the sham arm vs the average 20-minute change of the 20-minute and 60-minute auricular stimulation. Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment.

    Baseline, 20 minutes after the stimulation is initiated

Secondary Outcomes (20)

  • Area Under Curve

    120 minutes after stimulation is initiated.

  • 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.

    120 minutes after stimulation is initiated.

  • 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.

    120 minutes after stimulation is initiated.

  • Timed Get Up and Go test prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.

    120 minutes after stimulation is initiated.

  • Clinical Global Impression of Change (CGIC) prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.

    Baseline, 120 minutes after stimulation is initiated.

  • +15 more secondary outcomes

Study Arms (3)

Active Stimulation 20 minutes

ACTIVE COMPARATOR

Intramuscular stimulation

Device: Earstim - Active Stimulation

Active Stimulation 60 minutes

ACTIVE COMPARATOR

Intramuscular stimulation

Device: Earstim - Active Stimulation

Sham Stimulation 20 minutes

SHAM COMPARATOR

Muscle-free-zone stimulation

Device: Earstim - Sham Stimulation

Interventions

Earstim - Active StimulationDEVICE

Intramuscular stimulation

Active Stimulation 20 minutesActive Stimulation 60 minutes
Earstim - Sham StimulationDEVICE

Sham stimulation

Sham Stimulation 20 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is a male or female ≥18 years of age.
  • Subject has Parkinson's Disease and is on levodopa therapy.
  • 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).
  • The subject's daily "OFF" time duration is ≥2 hours per day.
  • 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).
  • Subject receives levodopa at least TID with a minimum of 100 mg levodopa administered with each dose.
  • Subject can tolerate 2 hours in an "OFF" period without requiring rescue medication.
  • Subject is willing and able to not change Parkinson's Disease medications or dosages during the up to 2 week study therapy period.
  • Subject is willing to provide Informed Consent to participate in the study.
  • Subject is willing and able to comply with all study procedures and required availability for study visits.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Southern California

Los Angeles, California, 90033, United States

Location

Rocky Mountain Movement Disorder's Center, PC

Englewood, Colorado, 80113, United States

Location

Parkinson Disease and Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Yusuf O Cakmak, MD, PhD

    Stoparkinson Healthcare Systems LLC

    STUDY DIRECTOR

  • Stanley Fahn, MD

    H. Houston Merritt Professor of Neurology, Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

December 3, 2020

Study Start

May 1, 2021

Primary Completion

January 5, 2022

Study Completion

January 5, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(8)