Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Electrical Stimulation; Other: Dry Needling Stimulation

• Registration Number: NCT03320681
• Lead Sponsor: Inventram

Brief Summary

Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

Detailed Description

Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

Study Timeline

• Study Start: 2017-05-20
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Arm && Interventions

Group	Intervention	Description
Active Stimulation	Electrical Stimulation	Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.
Dry Needling	Dry Needling Stimulation	Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given

Primary Outcome Measures

Name	Time	Method
fMRI - STN, PPN and cortical connectivity alterations	Baseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the motor and supplementary cortex	Baseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)	Baseline and PostStim (right after the stimulation is terminated)

Trial Locations

Locations (1)

Koc University Hospital; 🇹🇷 İstanbul, Turkey