Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms
Not Applicable
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT02722824
- Lead Sponsor
- Koç University
- Brief Summary
Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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 Change in the UPDRS Motor Score (Part III) 30 minutes after the stimulation is terminated. Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
- Secondary Outcome Measures
Name Time Method Change in the gait and balance parameters (cadence) 30 minutes after the stimulation is terminated. cadence
Change in the gait and balance parameters (Stride length) 30 minutes after the stimulation is terminated. Stride length in meters
Change in the gait and balance parameters (Stride velocity) 30 minutes after the stimulation is terminated. Stride velocity in m/s
Change in the gait and balance parameters 30 minutes after the stimulation is terminated. Trunk Joint Angles
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie bilateral extracranial electrostimulation of the supplementary motor area and subthalamic nucleus in Parkinson's Disease?
How does non-invasive electrostimulation compare to deep brain stimulation and levodopa in managing Parkinson's motor symptoms?
Which biomarkers, such as dopamine transporter imaging or alpha-synuclein levels, predict response to bilateral extracranial electrostimulation in Parkinson's Disease?
What are the known or potential adverse events of wearable electrostimulation devices targeting the supplementary motor area and subthalamic nucleus in Parkinson's patients?
Are there synergistic effects when combining wearable electrostimulation with dopamine agonists or MAO-B inhibitors in Parkinson's Disease management?
Trial Locations
- Locations (2)
Istanbul University
🇹🇷İstanbul, Turkey
Koc University Hospital
🇹🇷İstanbul, Turkey
Istanbul University🇹🇷İstanbul, Turkey