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NCT05968703 | RECRUITING | Parkinson's Disease

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

Helen M. Bronte-Stewart

Information provided by (Responsible Party):

Helen M. Bronte-Stewart

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.

Condition or disease

Parkinson's Disease

Mild Cognitive Impairment

Intervention/treatment

Combined STN+NBM DBS

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
Actual Study Start Date : 2025-04-08
Estimated Primary Completion Date : 2027-01-31
Estimated Study Completion Date : 2027-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease

Location Details

NCT05968703

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How to Participate

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Locations

RECRUITING

United States, California

Stanford Neuroscience Health Center

Stanford, California, United States, 94305