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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03320681

Enrollment

Registered

2017-10-25

Start date

2017-05-20

Completion date

2017-12-31

Last updated

2018-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Neurostimulator

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.

Interventions

DEVICEElectrical Stimulation

Percutaneous electrical nerve stimulation

OTHERDry Needling Stimulation

Percutaneous nerve stimulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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
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)
fMRI - STN, PPN and cortical connectivity alterations	Baseline and PostStim (right after the stimulation is terminated)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026