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Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms

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ClinicalTrials.gov Identifier: NCT02722824
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Istanbul University
Information provided by (Responsible Party):
Yasemin Gürsoy Özdemir, Koç University

Brief Summary:
Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Electro-stimulation Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes
Other: Placebo
Experimental: Active Stimulation
Instrinsic auricular muscles will be stimulated for 20 minutes
Device: Electro-stimulation
Sham Comparator: Sham
An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes
Device: Electro-stimulation
No Intervention: Passive Control
Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes



Primary Outcome Measures :
  1. Change in the UPDRS Motor Score (Part III) [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation

  2. Change in the UPDRS Motor Score (Part III) [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.


Secondary Outcome Measures :
  1. Change in the gait and balance parameters (cadence) [ Time Frame: 10 minutes after the stimulation is initiated. ]
    cadence

  2. Change in the gait and balance parameters (Stride length) [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Stride length in meters

  3. Change in the gait and balance parameters (Stride velocity) [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Stride velocity in m/s

  4. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Arm Swing Rate

  5. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Arm Range of Motion

  6. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Sit to Stand Duration

  7. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Sit to Stand Peak Trunk Velocity

  8. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Sit to Stand Peak Trunk Angle

  9. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Leg Swing Rate

  10. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Leg Range of Motion

  11. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Turn to Sit Peak Turn Velocity

  12. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Turn-to-Sit Trunk Range of Motion in Sagittal Plane

  13. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Knee Range of Motion

  14. Change in the gait and balance parameters [ Time Frame: 10 minutes after the stimulation is initiated. ]
    Trunk Joint Angles

  15. Change in the gait and balance parameters (cadence) [ Time Frame: 30 minutes after the stimulation is terminated. ]
    cadence

  16. Change in the gait and balance parameters (Stride length) [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Stride length in meters

  17. Change in the gait and balance parameters (Stride velocity) [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Stride velocity in m/s

  18. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Arm Swing Rate

  19. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Arm Range of Motion

  20. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Sit to Stand Duration

  21. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Sit to Stand Peak Trunk Velocity

  22. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Sit to Stand Peak Trunk Angle

  23. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Leg Swing Rate

  24. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Leg Range of Motion

  25. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Turn-to-Sit Peak Turn Velocity

  26. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Turn-to-Sit Trunk Range of Motion

  27. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Knee Range of Motion

  28. Change in the gait and balance parameters [ Time Frame: 30 minutes after the stimulation is terminated. ]
    Trunk Joint Angles



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:

  • Diagnosis of Parkinson's Disease
  • H&Y Stage >= 2
  • Existing bradykinesia symptoms
  • Existence of one of the symptoms below
  • Resting Tremor
  • Rigidity
  • Walking disorder

Exclusion Criteria:

  • Cardiac Pacemaker
  • Psychiatric diagnosis
  • Irregular heart/respiration rate
  • Pregnancy
  • Alcohol consumption
  • Cardiovascular disease history
  • Wearing an electro-active prosthesis
  • Brain surgery history
  • Ongoing TENS/PENS therapy

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): NCT02722824


Locations
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Turkey
Istanbul University
İstanbul, Turkey
Koc University Hospital
İstanbul, Turkey
Sponsors and Collaborators
Koç University
Istanbul University

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Responsible Party: Yasemin Gürsoy Özdemir, Professor, Koç University
ClinicalTrials.gov Identifier: NCT02722824     History of Changes
Other Study ID Numbers: Par-01
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yasemin Gürsoy Özdemir, Koç University:
motor symptoms

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