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NCT05968703 · ClinicalTrials.gov registry record · NA
Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
A NA study of Mild Cognitive Impairment and Parkinson's Disease, sponsored by Helen M. Bronte-Stewart.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05968703 is a NA study of Mild Cognitive Impairment and Parkinson's Disease that is actively recruiting participants, run by Helen M. Bronte-Stewart. The registered enrollment target is 10 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05968703, a NA study of Mild Cognitive Impairment and Parkinson's Disease, is actively recruiting participants, sponsored by Helen M. Bronte-Stewart.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Combined STN+NBM DBS
Study Locations (1)
California
- Stanford Neuroscience Health Center - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-04-08 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05968703
The ClinicalTrials.gov registry entry for NCT05968703 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The listed sponsor is Helen M. Bronte-Stewart, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which Combined STN+NBM DBS is the first listed.
NCT05968703 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05968703 about?
NCT05968703 is a clinical study titled "Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease". 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 ...
What is the current status of trial NCT05968703?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-04-08. Estimated completion is 2027-07-31.
What conditions does trial NCT05968703 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Parkinson's Disease.
What interventions are being tested in trial NCT05968703?
The interventions under investigation include: Combined STN+NBM DBS (DEVICE).
Who is sponsoring clinical trial NCT05968703?
This trial is sponsored by Helen M. Bronte-Stewart, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05968703 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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