Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms

Parkinson's Disease Clinical Trial

Official title:

Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722824
• Other study ID #: Par-01
• Status: Completed
• Phase: N/A
• First received: March 6, 2016
• Last updated: July 24, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Electro-stimulation

Other:
• Placebo

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul
Turkey	Koc University Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Koç University	Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the UPDRS Motor Score (Part III)	Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation	10 minutes after the stimulation is initiated.
Primary	Change in the UPDRS Motor Score (Part III)	Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters (cadence)	cadence	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters (Stride length)	Stride length in meters	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters (Stride velocity)	Stride velocity in m/s	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Arm Swing Rate	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Arm Range of Motion	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Sit to Stand Duration	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Sit to Stand Peak Trunk Velocity	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Sit to Stand Peak Trunk Angle	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Leg Swing Rate	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Leg Range of Motion	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Turn to Sit Peak Turn Velocity	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Turn-to-Sit Trunk Range of Motion in Sagittal Plane	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Knee Range of Motion	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters	Trunk Joint Angles	10 minutes after the stimulation is initiated.
Secondary	Change in the gait and balance parameters (cadence)	cadence	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters (Stride length)	Stride length in meters	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters (Stride velocity)	Stride velocity in m/s	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Arm Swing Rate	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Arm Range of Motion	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Sit to Stand Duration	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Sit to Stand Peak Trunk Velocity	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Sit to Stand Peak Trunk Angle	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Leg Swing Rate	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Leg Range of Motion	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Turn-to-Sit Peak Turn Velocity	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Turn-to-Sit Trunk Range of Motion	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Knee Range of Motion	30 minutes after the stimulation is terminated.
Secondary	Change in the gait and balance parameters	Trunk Joint Angles	30 minutes after the stimulation is terminated.