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DBS Surgery for Parkinson's Disease (PPNGB01 Trial)
N/A
Waitlist Available
Led By Guillermo Moguel-Cobos, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ambulatory and able to walk for limited periods of time without using an assistive device
18-75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 months
Awards & highlights
PPNGB01 Trial Summary
This trial is testing a new way to treat Parkinson's by stimulating different areas of the brain. The goal is to see if this new method can improve symptoms like walking and balance.
Who is the study for?
This trial is for people aged 18-75 with Parkinson's Disease stages 2-3, who have trouble walking and balancing despite taking Levodopa. They must be able to walk a bit without help, speak English, and be fit for surgery. Pregnant women or those with implanted devices like pacemakers can't join.Check my eligibility
What is being tested?
The study tests how Deep Brain Stimulation (DBS) at two brain sites affects attention, gait, and balance in Parkinson's patients. Participants will get electrodes in the subthalamic nucleus (STN) and an experimental site called the pedunculopontine nucleus (PPN).See study design
What are the potential side effects?
Potential side effects of DBS may include headache, confusion, speech problems, balance issues, tingling sensations or muscle contractions near the implantation area. There might also be risks associated with surgery such as infection.
PPNGB01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk by myself for short periods.
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I am between 18 and 75 years old.
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My Parkinson's is stage 2-3, worsens when I move, and doesn't improve with my current medication.
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My condition improves by at least 30% with levodopa.
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I experience shaking or movement issues due to my medication.
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I have had trouble walking or have fallen at least once in the past year.
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I am medically approved for surgery and anesthesia.
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I have been diagnosed with Parkinson's disease for at least 4 years.
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I am physically and mentally able to participate in study procedures.
PPNGB01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accidental Falls
Secondary outcome measures
STN-PPN on Attention
STN-PPN on Linear and Nonlinear Measures of Balance
STN-PPN on Linear and Nonlinear Measures of Gait
+4 morePPNGB01 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STN-PPN DBSExperimental Treatment1 Intervention
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 II: STN DBSActive Control1 Intervention
Subjects will receive traditional bilateral STN devices and stimulation.
Find a Location
Who is running the clinical trial?
Arizona State UniversityOTHER
283 Previous Clinical Trials
109,506 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,697 Total Patients Enrolled
Guillermo Moguel-Cobos, MDPrincipal InvestigatorMuhammad Ali Movement Disorders Clinic Physician
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need specific treatments like rTMS or ECT for my condition.You have a medical device implanted in your body, such as a pacemaker or neurostimulator.I have a history of seizures.I can walk by myself for short periods.You have a history of schizophrenia, believing things that are not true, or seeing things that are not really there and it is not currently controlled.I am between 18 and 75 years old.I don't have any health conditions that would make surgery risky for me.You are eligible for treatment that targets a specific part of the brain called the STN, according to a group of experts.My Parkinson's is stage 2-3, worsens when I move, and doesn't improve with my current medication.My condition improves by at least 30% with levodopa.I experience shaking or movement issues due to my medication.You have tried to harm yourself in the past year.I have had trouble walking or have fallen at least once in the past year.I am a woman who can have children and have a negative pregnancy test before surgery.I am medically approved for surgery and anesthesia.You are eligible for deep brain stimulation (DBS) according to the guidelines from the U.S. Food and Drug Administration (FDA).I have been diagnosed with Parkinson's disease for at least 4 years.I am physically and mentally able to participate in study procedures.You have a medical condition that prevents you from having an MRI scan.You have been diagnosed with dementia according to specific guidelines.I have a brain condition that is not Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: STN-PPN DBS
- Group 2: STN DBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial offer participation to individuals under twenty years of age?
"Those who are of legal age or above and below 75 years old may join this medical trial."
Answered by AI
Who is eligible to take part in this experiment?
"This medical trial is looking for 8 patients, aged 18 to 75 years old, who have been diagnosed with Parkinson's disease. The ideal candidate must also display any tremor or motor complications such as wearing off and/or dyskinesia; fall under the consensus committee's recommendations for STN targeting; present PD Stage 2-3 symptoms that are primarily axial in nature and unresponsive Levodopa > 600 mg doses; be ambulatory without requiring an assistive device; demonstrate gait instability or a history of at least one fall within the last year on tests of Static or Dynamic Stability."
Answered by AI
Are there opportunities for participants to enroll in this clinical trial at the present time?
"At this moment, the details on clinicaltrials.gov indicate that this trial is not accepting applicants. Initially posted November 1st 2021 and last updated May 5th 2022, it does not seem to be searching for volunteers currently; however there are 489 alternative studies still looking for participants."
Answered by AI
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