STEM-PD

Condition: Parkinson’s disease

Eligibility

Key Inclusion Criteria:

  • 18-85 years old
  • Diagnosed with Parkinson’s disease according to the UK Brain Bank Criteria 
  • Must have demonstrated a positive response to oral dopamine replacement therapy (DRT); treated with oral DRTs for minimum of 3 years prior to the screening visit

Key Exclusion Criteria:

  • Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
  • History or prior diagnosis of dementia or adjusted score ≤20 on the Montreal Cognitive Assessment at the screening visit
  • Experienced a myocardial infarction, angina or stroke within the past 12 months or a transient ischemic attack within 6 months

Study Name

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 (IRB no. 00001606)

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.

Principal Investigator

Contact