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Clinical Trials/NCT03320681
NCT03320681
Completed
Not Applicable

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

Inventram1 site in 1 country11 target enrollmentMay 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Inventram
Enrollment
11
Locations
1
Primary Endpoint
fMRI - STN, PPN and cortical connectivity alterations
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2017
End Date
December 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Inventram
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

fMRI - STN, PPN and cortical connectivity alterations

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

fMRI - Activation level comparison of the motor and supplementary cortex

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

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)

Study Sites (1)

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