Parkinson's Disease: Non-Invasive Brainstem Modulation for the Management of Non-Motor Symptoms

What is the Purpose of this Study?

This study focuses on individuals who have Parkinson's disease (PD) and are fully vaccinated from COVID-19 (coronavirus). The purpose of the study is to evaluate the safety and effectiveness of an investigational neuromodulation device for the treatment of non-motor symptoms in people with PD. Researchers aim to determine whether the non-invasive neuromodulation treatment effectively improves non-motor symptoms and/or improves overall quality of life in these patients. A non-invasive device stays outside of the body (is not implanted and does not penetrate the skin). Neuromodulation means that the device stimulates activity in the brain. The device consists of a headset and a base station that powers the headset. When activated, it will deliver a prescribed stimulation pattern for approximately 20 minutes. Participants will be randomly assigned to 1 of 2 treatment groups. Each group will use the same study device but will receive a different treatment mode (neurostimulation pattern). Participants will also be asked to complete multiple assessments and questionnaires.


Eligibility

  • Completion of the study activities in the STEM-PD RCT trial. l.
  • Participants must be willing and able to give consent to participate in the study trial.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Non-Invasive Brainstem Modulation for the Management of Non-motor symptoms in Parkinson's Disease: A Randomized Controlled Trial and an Open Label Extension Study

Study Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Co-Investigators

Echo Tan, Elliot Hogg

Age Group

Adult

Phase

Not Available

IRB Number

STUDY00001606

ClinicalTrials.gov ID

NCT04799418

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

Not Available

IRB Number

STEM-PD

ClinicalTrials.gov ID

NCT04799418

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org