Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)

January 7, 2022 updated by: Stoparkinson Healthcare Systems LLC

Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Movement Disorder's Center, PC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson Disease and Movement Disorder Center of Boca Raton
      • Gainesville, Florida, United States, 32608
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
      • Chicago, Illinois, United States, 60612
        • Rush University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Washington
      • Kirkland, Washington, United States, 98034
        • Booth Gardner Parkinson's Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Active Stimulation 20 minutes
Intramuscular stimulation
Device: Earstim - Active Stimulation
Intramuscular stimulation
ACTIVE_COMPARATOR: Active Stimulation 60 minutes
Intramuscular stimulation
Device: Earstim - Active Stimulation
Intramuscular stimulation
SHAM_COMPARATOR: Sham Stimulation 20 minutes
Muscle-free-zone stimulation
Device: Earstim - Sham Stimulation
Sham stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Score) at 20 minutes
Time Frame: Baseline, 20 minutes after the stimulation is initiated
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under Curve
Time Frame: 120 minutes after stimulation is initiated.
The area under the curve (AUC) of change from prior to stimulation in MDS-UPDRS Part III total motor score over the entire 120 minute post-stimulation follow-up interval, comparing the sham treatment to the 20 and 60 minute treatments with auricular muscle zone stimulation by subject and by treatment group.
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.
Time Frame: 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 (20 ,40, 60, 90, and 120 minutes after onset of 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
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.
Time Frame: 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 (20,40, 60, 90, and 120 minutes after onset of stimulation). Seven point Likert scale ranging from 1= much worse to 7= much better
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.
Time Frame: 120 minutes after stimulation is initiated.
Timed Get Up and Go test prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 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.
Time Frame: Baseline, 120 minutes after stimulation is initiated.
Clinical Global Impression of Change (CGIC) prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). Seven point Likert scale ranging from 1= much worse to 7= much better
Baseline, 120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated
Determination by the investigator of dyskinesia severity by MDS-UPDRS Part IV prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). dyskinesia severity is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment
120 minutes after stimulation is initiated
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.
Time Frame: 120 minutes after stimulation is initiated.
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 (20 ,40, 60, 90, and 120 minutes after onset of stimulation).
120 minutes after stimulation is initiated.
Change in mood as measured by the Depressed Mood Score from baseline to 120 minutes after onset of stimulation.
Time Frame: 120 minutes after stimulation is initiated.
Change in mood as measured by the Depressed Mood Score in Part I of MDS-UPDRS from pre-stimulation to 120 minutes after onset of stimulation.
120 minutes after stimulation is initiated.
Change in mood as measured by the Anxiety Mood Score from baseline to 120 minutes after onset of stimulation.
Time Frame: 120 minutes after stimulation is initiated.
Change in mood as measured by the Anxiety Mood Score in Part I of MDS-UPDRS from pre-stimulation to 120 minutes after onset of stimulation.
120 minutes after stimulation is initiated.
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.
Time Frame: 120 minutes after stimulation is initiated.
Change in subjects' sense of well-being as measured by an exploratory ordinal scale prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). Scores ranged from +3 to -3 (+3 represents more comfortable - much greater peace of mind; and -3 represents more uncomfortable and have a much greater worse peace of mind
120 minutes after stimulation is initiated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stoparkinson Healthcare Systems LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Parkinson Study Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yusuf O Cakmak, MD, PhD, Stoparkinson Healthcare Systems LLC
  • Principal Investigator: Stanley Fahn, MD, H. Houston Merritt Professor of Neurology, Columbia University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STP-PD-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings