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

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ClinicalTrials.gov Identifier: NCT04652583
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
The Parkinson Study Group
Information provided by (Responsible Party):
Stoparkinson Healthcare Systems LLC

Tracking Information
First Submitted Date  ICMJE November 10, 2020
First Posted Date  ICMJE December 3, 2020
Last Update Posted Date March 23, 2021
Estimated Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • 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.
  • 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
  • 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
  • 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).
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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).
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Auricular Muscle Zone Stimulation for Parkinson Disease
Official Title  ICMJE Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Device: Earstim - Active Stimulation
    Intramuscular stimulation
  • Device: Earstim - Sham Stimulation
    Sham stimulation
Study Arms  ICMJE
  • Active Comparator: Active Stimulation 20 minutes
    Intramuscular stimulation
    Intervention: Device: Earstim - Active Stimulation
  • Active Comparator: Active Stimulation 60 minutes
    Intramuscular stimulation
    Intervention: Device: Earstim - Active Stimulation
  • Sham Comparator: Sham Stimulation 20 minutes
    Muscle-free-zone stimulation
    Intervention: Device: Earstim - Sham Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2020)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Burak Ozsoy, PhD +90 216 227 2700 burako@stoparkinson.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04652583
Other Study ID Numbers  ICMJE STP-PD-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stoparkinson Healthcare Systems LLC
Study Sponsor  ICMJE Stoparkinson Healthcare Systems LLC
Collaborators  ICMJE The Parkinson Study Group
Investigators  ICMJE
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
PRS Account Stoparkinson Healthcare Systems LLC
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP