Recruiting

STN & NBM

Sponsor:

Helen M. Bronte-Stewart

Code:

NCT05968703

Conditions

Parkinson's Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Combined STN+NBM DBS

Study Details

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

Study ID

NCT05968703

Start date

Apr 8, 2025

Status verified date

May, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vertical Nuclear Trajectory

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

experimental: Lateral NBM Bundle Trajectory

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

Interventions

Combined STN+NBM DBS

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

Primary outcome measure

  • Adverse Events [ Time Frame: From baseline to 1 year into treatment ]
  • Swing Time Coefficient of Variation [ Time Frame: From baseline to 1 year into treatment ]

Central Contacts and Locations

Central contacts

Study Coordinator

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

Locations

Stanford Neuroscience Health Center

Recruiting

Stanford, California, United States, 94305

Contacts

Study Coordinator

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

More Information

Sponsor

Helen M. Bronte-Stewart

Last update posted

May 30, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Helen M. Bronte-Stewart on 2025-05-30.