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

Helen M. Bronte-Stewart

Status: Enrolling

Conditions: Mild Cognitive Impairment; Parkinson's Disease

Treatments: Device: Combined STN+NBM DBS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05968703

UH3NS128150 (U.S. NIH Grant/Contract)

70608

UG3NS128150 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Vertical Nuclear Trajectory

Experimental group

Description:

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

Treatment:

Device: Combined STN+NBM DBS

Lateral NBM Bundle Trajectory

Experimental group

Description:

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

Treatment:

Device: Combined STN+NBM DBS