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

May 23, 2018 updated by: Inventram

Effect Mechanism 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Koç University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Stimulation
Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.
Device: Electrical Stimulation
Percutaneous electrical nerve stimulation
Other: Dry Needling
Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given
Other: Dry Needling Stimulation
Percutaneous nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI - Activation level comparison of the motor and supplementary cortex
Time Frame: Baseline and PostStim (right after the stimulation is terminated)
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)
Baseline and PostStim (right after the stimulation is terminated)
fMRI - STN, PPN and cortical connectivity alterations
Time Frame: Baseline and PostStim (right after the stimulation is terminated)
Baseline and PostStim (right after the stimulation is terminated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inventram

Collaborators

Koç University

Investigators

  • Principal Investigator: Yusuf O Cakmak, Phd, MD, Otago University
  • Study Director: Burak Ozsoy, PhD, Inventram

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Par-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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