Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
1 other identifier
interventional
11
1 country
1
Brief Summary
Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started May 2017
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2017
CompletedFirst Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMay 24, 2018
May 1, 2018
8 months
August 16, 2017
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
fMRI - Activation level comparison of the motor and supplementary cortex
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)
Baseline and PostStim (right after the stimulation is terminated)
fMRI - STN, PPN and cortical connectivity alterations
Baseline and PostStim (right after the stimulation is terminated)
Study Arms (2)
Active Stimulation
ACTIVE COMPARATORAcupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.
Dry Needling
OTHERAcupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Parkinson's Disease
- H\&Y Stage \>= 2
- Existing bradykinesia symptoms
- Existence of one of the symptoms below
- Resting Tremor
- Rigidity
- Walking disorder
You may not qualify if:
- 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-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inventramlead
- Koç Universitycollaborator
Study Sites (1)
Koc University Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yusuf O Cakmak, Phd, MD
Otago University
- STUDY DIRECTOR
Burak Ozsoy, PhD
Inventram
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
October 25, 2017
Study Start
May 20, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
May 24, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share