Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
Not Applicable
Completed
- Conditions
- Parkinson Disease
- Registration Number
- NCT03320681
- Lead Sponsor
- Inventram
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method fMRI - STN, PPN and cortical connectivity alterations Baseline and PostStim (right after the stimulation is terminated) 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Koc University Hospital
🇹🇷İstanbul, Turkey
Koc University Hospital🇹🇷İstanbul, Turkey