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Procedure

Closed Loop DBS for Parkinson's Disease

N/A

Recruiting

Led By Helen M. Bronte-Stewart, MD,MSE

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18

Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1

Must not have

Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications

History of seizures or epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of DBS that can adapt to a patient's needs, in order to better treat symptoms of Parkinson's disease.

Who is the study for?

This trial is for adults over 18 with Parkinson's Disease who experience gait issues despite medication. They must be eligible for or already have a specific deep brain stimulation device implanted and can attend follow-up visits. Exclusions include dementia, certain medical devices like pacemakers, severe health conditions, pregnancy, metal implants in the skull, seizures, and advanced-stage Parkinson's.

What is being tested?

The study tests an adaptive Deep Brain Stimulation (DBS) system that adjusts its settings based on real-time feedback from the patient's neural activity and movement patterns. It aims to improve walking difficulties in Parkinson’s patients by customizing treatment to their immediate needs.

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 implant site. These are generally related to the surgery or adjustments made to stimulation settings.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I experience freezing when I walk.

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I am eligible for or already have a specific brain stimulation device.

Exclusion Criteria

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

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I don't have severe high blood pressure, bleeding disorders, or metabolic conditions that could complicate surgery.

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I have a history of seizures or epilepsy.

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I have a psychiatric condition that has not been treated.

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I need rTMS, ECT, MRI, or diathermy treatments.

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I am over 80 years old.

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I cannot walk, even with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to gait

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to quality of life

+1 more

Secondary study objectives

Gait Parameters: Arrhythmicity

Gait Parameters: Mean Gait Cycle Time

Gait Parameters: Mean Shank Angular Velocity

+2 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

Group I: Device: Summit RC+SExperimental Treatment3 Interventions

1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state 3. Intermittent Open Loop DBS: Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.

Group II: Device: Percept PCExperimental Treatment2 Interventions

1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state

0 / 9Eligibility criteria met