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
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring Neurostimulator
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-
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
Learn more about this trial
Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
We'll reach out to this number within 24 hrs