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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: Recruiting NA study of Mild Cognitive Impairment and Parkinson's Disease, sponsored by Helen M. Bronte-Stewart.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study

Interventions

  • DEVICE Combined STN+NBM DBS

Study Locations (1)

California

  • Stanford Neuroscience Health Center - Stanford

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-04-08
Est. Completion 2027-07-31
Phase NA
Helen M. Bronte-Stewart

1 total trials

What NCT05968703 shows while recruiting

NCT05968703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

Similar trials for Mild Cognitive Impairment

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05968703's enrollment target sits among peer trials

10 199th of 205 higher than 6 of 205 other Mild Cognitive Impairment trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05968703, the US trial registry maintained by the National Library of Medicine. NCT05968703 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.