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Completed

NCT Number: NCT02722824

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electro-stimulation

Device

Placebo

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Koç University

Other

Collaborators

  • Istanbul University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2016
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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