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Device

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

Must not have

Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition

Subjects with a history of seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 months

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need specific treatments like rTMS or ECT for my condition.

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I have a history of seizures.

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I don't have any health conditions that would make surgery risky for me.

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I have a brain condition that is not Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accidental Falls

Secondary study objectives

STN-PPN on Attention

STN-PPN on Linear and Nonlinear Measures of Balance

STN-PPN on Linear and Nonlinear Measures of Gait

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 13Eligibility criteria met