Clinical trial NCT02722824: Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms
Official title: Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: motor symptoms
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2016-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Change in the UPDRS Motor Score (Part III)
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the UPDRS Motor Score (Part III)
timeFrame: 30 minutes after the stimulation is terminated.
Secondary outcomes:
measure: Change in the gait and balance parameters (cadence)
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters (Stride length)
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters (Stride velocity)
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters
timeFrame: 10 minutes after the stimulation is initiated.
measure: Change in the gait and balance parameters (cadence)
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters (Stride length)
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters (Stride velocity)
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
measure: Change in the gait and balance parameters
timeFrame: 30 minutes after the stimulation is terminated.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University
city: İstanbul
country: Turkey
facility: Koc University Hospital
Study officials:
References: