NCT05968703Recruiting
Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is: Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled. Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 19 Jul 2023
- Start date
- 8 Apr 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Helen M. Bronte-Stewart
- Diseases
- Parkinson disease
- NCT number
- NCT05968703
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 8 Apr 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Dementia
- Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
- History of seizures
Other
- Pregnant
- Requires MRI
- Unable to walk 100 feet without an assistive device
Who the study is looking for
- 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
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford Neuroscience Health Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.