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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320681
• Other study ID #: Par-02
• Status: Completed
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: Inventram
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• 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

Intervention

Device:
• Electrical Stimulation
Percutaneous electrical nerve stimulation

Other:
• Dry Needling Stimulation
Percutaneous nerve stimulation

Locations

Country	Name	City	State
Turkey	Koc University Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Inventram	Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI - Activation level comparison of the motor and supplementary cortex		Baseline and PostStim (right after the stimulation is terminated)
Primary	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)
Primary	fMRI - STN, PPN and cortical connectivity alterations		Baseline and PostStim (right after the stimulation is terminated)