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

NCT ID: NCT04605263

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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This is a prospective, single-center randomized controlled trial designed to estimate the potential clinical benefit, and associated risks, of deep brain stimulation of the of the PPN and STN in patients with PD that are candidates for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with additional bilateral electrodes in the PPN. Each subject will be randomized 1:1 to one of the following sequences: Bilateral STN+PPN stimulation or Bilateral STN stimulation alone. The addition of a bilateral STN stimulation only group allows for the research of potential micro-lesioning effects of the PPN which might affect features of interest even in the absence of PPN stimulation.

Conditions

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Parkinson Disease

Keywords

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Deep Brain Simulation (DBS) Gait and Balance Postural Instability and Gait Dysfunction (PIGD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will be randomly assigned (1:1) to receive either traditional STN stimulation or STN+PPN patients. Once implanted, all patients will receive stimulation of all implanted devices for the first three months to allow for stimulation parameters to be adjusted. During this time, STN+PPN subjects will have their PPN stimulation parameters mapped (all DBS contacts in the PPN will be tested to determine which stimulation pattern achieves best results). Once patients have been tested at the 3-month post-op visit, STN+PPN patients will be double-blindly randomized (1:1) to either receive or not receive PPN stimulation for the following six months before further testing. Following the 9-month testing visit, STN+PPN patients will be crossed over so that those receiving PPN stimulation before will have their device turned off, and vice versa. After further testing at 15 months, all patients will have their devices turned back on. There will be one final test at 27 months.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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STN DBS

Subjects will receive traditional bilateral STN devices and stimulation.

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation Surgery (DBS)

Intervention Type PROCEDURE

DBS lead implantation of bilateral STN

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.

Group Type EXPERIMENTAL

STN-PPN DBS Surgery

Intervention Type DEVICE

Subject will undergo standard bilateral STN DBS surgery and have 2 additional leads placed in the same burr with bilateral PPN targets

Interventions

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STN-PPN DBS Surgery

Subject will undergo standard bilateral STN DBS surgery and have 2 additional leads placed in the same burr with bilateral PPN targets

Intervention Type DEVICE

Deep Brain Stimulation Surgery (DBS)

DBS lead implantation of bilateral STN

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Informed consent signed by the subject.
2. Diagnosed with Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria for at least 4 years
3. Demonstrates levodopa responsiveness of at least 30%
4. Experiences tremor or motor complications including wearing off and/or dyskinesia
5. DBS candidate per FDA guidelines as outlined in criteria 2-4
6. Candidate for STN targeting per the consensus committee
7. Subject exhibits gait instability, or a history of at least one fall within the last year, or a history of falls on tests of Static or Dynamic Stability.
8. PD Stage 2-3 with predominant axial symptoms or FOG refractory to Levodopa \> 600 mg and UPDRS Part III Subscore of \>6.
9. Subject is ambulatory and able to walk for limited periods of time without using an assistive device.
10. 18-75 years of age
11. Primary English speaking
12. Physically and cognitively capable of completing evaluations and consent
13. Medically cleared for surgery and anesthesia
14. Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery

Exclusion Criteria

1. Dementia per DSM-V criteria
2. Condition precluding MRI
3. History of supraspinal CNS disease other than PD
4. History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
5. Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
6. Subjects with a history of seizure disorder
7. Subjects who have made a suicide attempt within the prior year,
8. Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
9. Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
10. Subjects who are pregnant or nursing.
11. Patient that is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
12. Any other reasons that, in the opinion of the investigator, the candidate is determined to be unsuitable for entry into the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona State University

OTHER

Sponsor Role collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillermo Moguel-Cobos, MD

Role: PRINCIPAL_INVESTIGATOR

Muhammad Ali Movement Disorders Clinic Physician

Locations

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St. Joseph's Hospital & Medical Center / Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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PHX-19-500-412-30-04

Identifier Type: -

Identifier Source: org_study_id