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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Electrical Stimulation

Dry Needling Stimulation

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Neurostimulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-

Sites / Locations

Koc University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Active Stimulation

Dry Needling

Arm Description

Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.

Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given

Outcomes

Primary Outcome Measures

fMRI - Activation level comparison of the motor and supplementary cortex

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

fMRI - STN, PPN and cortical connectivity alterations

Secondary Outcome Measures

Full Information

NCT ID

NCT03320681

First Posted

August 16, 2017

Last Updated

May 23, 2018

Sponsor

Inventram

Collaborators

Koç University

1. Study Identification

Unique Protocol Identification Number

NCT03320681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

May 20, 2017 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inventram

Collaborators

Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Neurostimulator

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Double-blind

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Stimulation

Arm Type

Active Comparator

Arm Description

Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.

Arm Title

Dry Needling

Arm Type

Other

Arm Description

Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given

Intervention Type

Device

Intervention Name(s)

Electrical Stimulation

Intervention Description

Percutaneous electrical nerve stimulation

Intervention Type

Other

Intervention Name(s)

Dry Needling Stimulation

Intervention Description

Percutaneous nerve stimulation

Primary Outcome Measure Information:

Title

fMRI - Activation level comparison of the motor and supplementary cortex

Time Frame

Baseline and PostStim (right after the stimulation is terminated)

Title

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)

Title

fMRI - STN, PPN and cortical connectivity alterations

Time Frame

Baseline and PostStim (right after the stimulation is terminated)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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-

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yusuf O Cakmak, Phd, MD

Organizational Affiliation

Otago University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Burak Ozsoy, PhD

Organizational Affiliation

Inventram

Official's Role

Study Director

Facility Information:

Facility Name

Koc University Hospital

City

İstanbul

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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