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

Not Applicable
Completed
Conditions
Parkinson Disease
Registration Number
NCT03320681
Lead Sponsor
Inventram
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
11
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-

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
fMRI - STN, PPN and cortical connectivity alterationsBaseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the motor and supplementary cortexBaseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)Baseline and PostStim (right after the stimulation is terminated)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Koc University Hospital

🇹🇷

İstanbul, Turkey

Koc University Hospital
🇹🇷İstanbul, Turkey

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