Parkinson's Disease
Conditions
Keywords
motor symptoms
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.
Interventions
DEVICEElectro-stimulation
OTHERPlacebo
Sponsors
Istanbul University
Koç University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the UPDRS Motor Score (Part III) | 10 minutes after the stimulation is initiated. | Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the gait and balance parameters (cadence) | 10 minutes after the stimulation is initiated. | cadence |
| Change in the gait and balance parameters (Stride length) | 10 minutes after the stimulation is initiated. | Stride length in meters |
| Change in the gait and balance parameters (Stride velocity) | 10 minutes after the stimulation is initiated. | Stride velocity in m/s |
| Change in the gait and balance parameters | 10 minutes after the stimulation is initiated. | Arm Swing Rate |
Countries
Turkey (Türkiye)
Outcome results
None listed