NCT02722824
Completed
Not Applicable
Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms
Koç University2 sites in 1 country24 target enrollmentNovember 2015
ConditionsParkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Koç University
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change in the UPDRS Motor Score (Part III)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Yasemin Gürsoy Özdemir
Professor
Koç University
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
- •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
Outcomes
Primary Outcomes
Change in the UPDRS Motor Score (Part III)
Time Frame: 30 minutes after the stimulation is terminated.
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
Secondary Outcomes
- Change in the gait and balance parameters (cadence)(30 minutes after the stimulation is terminated.)
- Change in the gait and balance parameters (Stride length)(30 minutes after the stimulation is terminated.)
- Change in the gait and balance parameters (Stride velocity)(30 minutes after the stimulation is terminated.)
- Change in the gait and balance parameters(30 minutes after the stimulation is terminated.)
Study Sites (2)
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