Parkinson DiseasePPNGB01NCT04605263
Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN)
A study testing STN-PPN DBS Surgery and Deep Brain Stimulation Surgery (DBS) in people with Parkinson Disease, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- STN-PPN DBS Surgery and Deep Brain Stimulation Surgery (DBS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed by the subject.
- Diagnosed with Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria for at least 4 years
- Demonstrates levodopa responsiveness of at least 30%
- Experiences tremor or motor complications including wearing off and/or dyskinesia
- DBS candidate per FDA guidelines as outlined in criteria 2-4
- Candidate for STN targeting per the consensus committee
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- 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.
- PD Stage 2-3 with predominant axial symptoms or FOG refractory to Levodopa > 600 mg and UPDRS Part III Subscore of >6.
- Subject is ambulatory and able to walk for limited periods of time without using an assistive device.
- 18-75 years of age
- Primary English speaking
- Physically and cognitively capable of completing evaluations and consent
- Medically cleared for surgery and anesthesia
- Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery
Who cannot join
- Dementia per DSM-V criteria
- Condition precluding MRI
- History of supraspinal CNS disease other than PD
- History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
- Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
- Subjects with a history of seizure disorder
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- Subjects who have made a suicide attempt within the prior year,
- Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
- Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
- Subjects who are pregnant or nursing.
- 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.
- Any other reasons that, in the opinion of the investigator, the candidate is determined to be unsuitable for entry into the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
St. Joseph's Hospital & Medical Center / Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: Effects of Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) on Gait, Postural Stability, Freezing of Gait (FOG), and Falls
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.
Read the detailed description
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
- Parkinson Disease
- Being tested
- STN-PPN DBS Surgery, Deep Brain Stimulation Surgery (DBS)
- Keywords
- Deep Brain Simulation (DBS), Gait and Balance, Postural Instability and Gait Dysfunction (PIGD)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN-PPN DBS SurgeryDevice
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 or surgery
DBS lead implantation of bilateral STN
| Study group | Role | What they receive |
|---|---|---|
| STN DBS | Active comparator | Subjects will receive traditional bilateral STN devices and stimulation. Receives: Procedure: Deep Brain Stimulation Surgery (DBS) |
| STN-PPN DBS | Experimental | 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. Receives: Device: STN-PPN DBS Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
STN-PPN Stimulation Effect on Fall Risk
The purpose of this study is to measure the effect and the mechanism of deep brain stimulation (DBS) of the pedunculopontine nucleus (PPN) on fall risk as established by quantitative gait and balance analysis.
Measured: 27 months
Secondary outcomes (7)
STN-PPN on Linear and Nonlinear Measures of Gait
Linear and nonlinear measured of gait will be measured during straight walking, turning, and arising and returning to a chair.
Measured: 27 months
STN-PPN on Linear and Nonlinear Measures of Balance
Linear and nonlinear measures of balance will be collected during eyes open, eyes closed, and perturbed (dyanic balance) conditions.
Measured: 27 months
STN-PPN on Attention
The effect of PPN stimulation, in comparison to that of STN alone, on attention, with be measured using the Conners Continuous Auditory Test of Attention and Continuous Performance Test 3.
Measured: 27 months
STN-PPN on Subjective Measures of Alertness
The effects of PPN stimulation on subjective function will be measured using the Toronto Alertness Scale, graded 0-50, with higher scores being better.
Measured: 27 months
STN-PPN on Subjective Measures of Sleep
The effects of PPN stimulation on subjective function will be measured using the Epworth Sleep Scale, graded 0-24, with lower scores being better.
Measured: 27 months
STN-PPN on Subjective Measures of Non-Motor Symptoms
The effects of PPN stimulation on subjective function will be measured using the Non-Motor Symptom Assessment, graded 0-360, with lower scores being better.
Measured: 27 months
STN-PPN on Subjective Measures of Balance in Daily Life
The effects of PPN stimulation on subjective function will be measured using the Activity-specific Balance Confidence Scale, graded on a scale of 0-100, with higher scores being better.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Nov 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Guillermo Moguel-Cobos, MD, Principal investigator, Muhammad Ali Movement Disorders Clinic Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605263
- Sponsor's protocol ID
- PHX-19-500-412-30-04
- Acronym
- PPNGB01
- Status last verified
- Nov 2024
- First submitted
- 31 Aug 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is a Data Use Agreement (DUA), with Boston Scientific.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) on Gait, Postural Stability, Freezing of Gait (FOG), and Falls
- ClinicalTrials.gov ID
- NCT04605263
- Acronym / sponsor ID
- PPNGB01 / PHX-19-500-412-30-04
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Simulation (DBS), Gait and Balance, Postural Instability and Gait Dysfunction (PIGD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| STN DBS | Active comparator | Procedure: Deep Brain Stimulation Surgery (DBS)Subjects will receive traditional bilateral STN devices and stimulation. |
| STN-PPN DBS | Experimental | Device: STN-PPN DBS SurgeryPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
Key exclusion criteria (12 listed)
- Dementia per DSM-V criteria
- Condition precluding MRI
- History of supraspinal CNS disease other than PD
- History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
- Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN-PPN DBS SurgerySubject will undergo standard bilateral STN DBS surgery and have 2 additional leads placed in the same burr with bilateral PPN targets | Device | STN-PPN DBS |
| Deep Brain Stimulation Surgery (DBS)DBS lead implantation of bilateral STN | Procedure or surgery | STN DBS |
Primary outcome
STN-PPN Stimulation Effect on Fall Risk
Time frame: 27 months
The purpose of this study is to measure the effect and the mechanism of deep brain stimulation (DBS) of the pedunculopontine nucleus (PPN) on fall risk as established by quantitative gait and balance analysis.
7 secondary outcomes
STN-PPN on Linear and Nonlinear Measures of Gait
Time frame: 27 months
STN-PPN on Linear and Nonlinear Measures of Balance
Time frame: 27 months
STN-PPN on Attention
Time frame: 27 months
STN-PPN on Subjective Measures of Alertness
Time frame: 27 months
STN-PPN on Subjective Measures of Sleep
Time frame: 27 months
STN-PPN on Subjective Measures of Non-Motor Symptoms
Time frame: 27 months
STN-PPN on Subjective Measures of Balance in Daily Life
Time frame: 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No. There is a Data Use Agreement (DUA), with Boston Scientific.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Moguel-Cobos, MD principal investigator
Muhammad Ali Movement Disorders Clinic Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STN-PPN DBS Surgery and Deep Brain Stimulation Surgery (DBS) in people with Parkinson Disease, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STN-PPN Stimulation Effect on Fall Risk (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.