Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease

NCT05968703 | Recruiting DMC FDA Device

• 3 other identifiers: 70608UG3NS128150UH3NS128150
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson's Disease; Mild Cognitive Impairment

Keywords

deep brain stimulation; cognition; DBS; parkinson's disease

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  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

  From baseline to 1 year into treatment

• Swing Time Coefficient of Variation

  Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.

  From baseline to 1 year into treatment

Secondary Outcomes (28)

• Percent Time Freezing

  From baseline to 1 year into treatment

• Stride Time Coefficient of Variation

  From baseline to 1 year into treatment

• Shank Angular Velocity

  From baseline to 1 year into treatment

• Tapping Speed

  From baseline to 1 year into treatment

• Tapping Rhythmicity

  From baseline to 1 year into treatment

Study Arms (2)

Vertical Nuclear Trajectory

EXPERIMENTAL

Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself.

Device: Combined STN+NBM DBS

Lateral NBM Bundle Trajectory

EXPERIMENTAL

Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM

Device: Combined STN+NBM DBS

Interventions

Combined STN+NBM DBS DEVICE

This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)

Lateral NBM Bundle Trajectory; Vertical Nuclear Trajectory

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helen M. Bronte-Stewart: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Stanford Neuroscience Health Center

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Helen M Bronte-Stewart, MD MSE

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

650-723-6709; bronte-stewart-lab@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 1, 2023
• Study Start: April 8, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The IPD is anticipated to be available in approximately three months after study completion
• Access Criteria: DABI is openly available

Locations

US (1)