STEM-PD

Summary

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.


Inclusion Criteria

  • 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.

Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001606

ClinicalTrials.gov ID
NCT04799418
Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

N/A

IRB Number

STEM-PD

ClinicalTrials.gov ID

NCT04799418

Key Eligibility
ClinicalTrials.gov
Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?