Deep brain stimulation for cognitive issues in Parkinson's disease
Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
This study is testing a new deep brain stimulation method to see if it can help improve thinking and movement problems in people with Parkinson's disease who have mild cognitive issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05968703 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of a novel deep brain stimulation (DBS) approach targeting both the Subthalamic Nucleus (STN) and the Nucleus Basalis of Meynert (NBM) to address cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The study aims to enroll ten participants who will receive four DBS leads, two in the STN and two in the NBM, utilizing innovative stimulation patterns to improve cognitive function. Participants will undergo modifications to the traditional DBS approach, with a focus on cognitive outcomes. The trial seeks to determine if this combined approach is safe and tolerable for patients with mild cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease who are approved or planning for STN deep brain stimulation and are willing to modify their medication regimen for the study.
Not a fit: Patients with dementia, unstable medical or psychiatric conditions, or those requiring MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function and quality of life for patients with Parkinson's disease experiencing mild cognitive impairment.
How similar studies have performed: While deep brain stimulation has been used for motor symptoms in Parkinson's disease, this combined approach targeting cognitive symptoms is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease (PD) * Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS) * Willingness to withdraw from clinical medication regimen when necessary for research visits * Ability to provide informed consent Exclusion Criteria: * Dementia * Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation * History of seizures * Pregnant * Requires MRI * Unable to walk 100 feet without an assistive device
Where this trial is running
Stanford, California
- Stanford Neuroscience Health Center — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Helen M Bronte-Stewart, MD MSE — Stanford University
- Study coordinator: Study Coordinator
- Email: bronte-stewart-lab@stanford.edu
- Phone: 650-723-6709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.