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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

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Earstim - Active Stimulation Device: Earstim - Sham Stimulation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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).

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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).

  18. 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.

  19. 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.

  20. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652583


Contacts
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Contact: Burak Ozsoy, PhD +90 216 227 2700 burako@stoparkinson.com

Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Contact: Mark Lew, MD         
United States, Colorado
Rocky Mountain Movement Disorder's Center, PC
Englewood, Colorado, United States, 80113
United States, Florida
Parkinson Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States, 33486
Contact: Stuart Isaacson, MD         
University of Florida
Gainesville, Florida, United States, 32608
Contact: Adolfo Ramirez-Zamora, MD         
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
Contact: Leo Verhagen, MD         
University of Chicago
Chicago, Illinois, United States, 60637
Contact: Tao Xie, MD         
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
Contact: Vibhash Sharma, MD         
United States, South Carolina
Prisma Health
Greenville, South Carolina, United States, 29615
Contact: Fredy Revilla, MD         
United States, Washington
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States, 98034
Contact: Pinky Agarwal, MD         
Sponsors and Collaborators
Stoparkinson Healthcare Systems LLC
The Parkinson Study Group
Investigators
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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
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Responsible Party: Stoparkinson Healthcare Systems LLC
ClinicalTrials.gov Identifier: NCT04652583    
Other Study ID Numbers: STP-PD-004
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases