Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT04605263
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • STN-PPN DBS Surgery — DEVICE
    Subject will undergo standard bilateral STN DBS surgery and have 2 additional leads placed in the same burr with bilateral PPN targets
  • Deep Brain Stimulation Surgery (DBS) — PROCEDURE
    DBS lead implantation of bilateral STN

Study Details

This is a mechanistic study to determine the differential effects of the dopaminergic and cholinergic systems on attention, gait, and balance. The primary goal of the study is to evaluate the relative effects of pedunculopontine nucleus (PPN) and subthalamic nucleus (STN) Deep Brain Stimulation (DBS) on these features in persons with Parkinson's Disease (PD) who are eligible for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with bilateral electrodes in one of the approved DBS locations (subthalamic nucleus: STN), but additionally electrodes will be inserted into the experimental target, namely the PPN bilaterally.

Key Dates

Start date
Nov 1, 2021
Status verified
Nov 2024
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: STN DBS
    Subjects will receive traditional bilateral STN devices and stimulation.
  • Experimental: STN-PPN DBS
    Patients will be implanted with both bilateral STN and bilateral PPN devices. These patients will undergo a crossover between 3 and 15 months post-op in which they will double-blindly receive PPN stimulation for six months and have stimulation turned off for six months. All patients will receive stimulation from 0-3 months post-op (mapping visits occur in this window) and from 15-27 months.

Primary Outcome Measure

STN-PPN Stimulation Effect on Fall Risk [ Time Frame: 27 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital & Medical Center / Barrow Neurological InstitutePhoenixArizona85013-

Find similar trials in Phoenix, AZ

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
St. Joseph's Hospital & Medical Center / Barrow Neurological Institute· Phoenix, AZ

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