Menu
Recruiting NCT05968703

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

No phase Interventional Parkinson's Disease Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined STN+NBM DBS.
Who it may be relevant to
Registry conditions: Parkinson's Disease, Mild Cognitive Impairment. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease

Overview

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.

Interventions

  • Device 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 measures

  • 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]
Secondary outcome measures (12)
  • Percent Time Freezing [Time frame: From baseline to 1 year into treatment]
  • Stride Time Coefficient of Variation [Time frame: From baseline to 1 year into treatment]
  • Shank Angular Velocity [Time frame: From baseline to 1 year into treatment]
  • Tapping Speed [Time frame: From baseline to 1 year into treatment]
  • Tapping Rhythmicity [Time frame: From baseline to 1 year into treatment]
  • MDS-UPDRS III Score [Time frame: From baseline to 1 year into treatment]
  • SAT Score [Time frame: From baseline to 1 year into treatment]
  • Percent False Positives [Time frame: From baseline to 1 year into treatment]
  • Percent Misses [Time frame: From baseline to 1 year into treatment]
  • Average + standard deviation of response time [Time frame: From baseline to 1 year into treatment]
  • Goal-directed focus of attention [Time frame: From baseline to 1 year into treatment]
  • Sustained attention [Time frame: From baseline to 1 year into treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Neuroscience Health Center — Stanford

Identifiers

NCT: NCT05968703 · 70608 · UG3NS128150 · UH3NS128150

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗