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Completed

NCT Number: NCT03320681

Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University Hospital

Istanbul, Turkey (Türkiye)

About this study

Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

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

Electrical Stimulation

Device

Percutaneous electrical nerve stimulation

Dry Needling Stimulation

Other

Percutaneous nerve stimulation

Primary outcomes

  1. fMRI - Activation level comparison of the motor and supplementary cortex

    Time frame: Baseline and PostStim (right after the stimulation is terminated)

  2. fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)

    Time frame: Baseline and PostStim (right after the stimulation is terminated)

  3. fMRI - STN, PPN and cortical connectivity alterations

    Time frame: Baseline and PostStim (right after the stimulation is terminated)

Sponsors and collaborators

Lead sponsor

Inventram

Industry

Collaborators

  • Koç University

Registry information

Official study title

Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2017
Registry last updated
May 24, 2018

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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