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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.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 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 belowSelect...
I am older than 18 years.
Select...
I experience freezing when I walk.
Select...
I am eligible for or already have a specific brain stimulation device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Gait Parameters: Arrhythmicity
Gait Parameters: Mean Gait Cycle Time
Gait Parameters: Mean Shank Angular Velocity
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Device: Summit RC+SExperimental Treatment3 Interventions
Open Loop DBS: Standard DBS therapy at a constant frequency and voltage
Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state
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
Open Loop DBS: Standard DBS therapy at a constant frequency and voltage
Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,581 Total Patients Enrolled
Helen M. Bronte-Stewart, MD,MSE4.06 ReviewsPrincipal Investigator - Stanford University
Stanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart device called a pacemaker or defibrillator.I am older than 18 years.I don't have severe high blood pressure, bleeding disorders, or metabolic conditions that could complicate surgery.I experience freezing when I walk.I have a history of seizures or epilepsy.Your nerve response is above a certain level in a specific test.I have a psychiatric condition that has not been treated.The participant has been diagnosed with Parkinson's disease.I need rTMS, ECT, MRI, or diathermy treatments.I am eligible for or already have a specific brain stimulation device.You have dementia.You have a metal implant in your head.I am over 80 years old.I cannot walk, even with medication.My medication for Parkinson's causes side effects that affect my life.
Research Study Groups:
This trial has the following groups:- Group 1: Device: Summit RC+S
- Group 2: Device: Percept PC
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 this trial have capacity for new participants?
"According to the clinicaltrials.gov webpage, this trial has been open for recruitment since October 28th 2019 and is still accepting participants. The page was refreshed on October 14th 2022 with updated information."
Answered by AI
Is this investigation open to those 45 and over?
"Based on the eligibility criteria, potential patients must be between 25 and 80 years of age to join this medical study."
Answered by AI
Could I potentially be approved to join this clinical trial?
"This clinical trial seeks to enroll 14 people with Parkinson's disease ranging from 25 years old to 80. To be eligible, patients must demonstrate clinically-established PD and meet the criteria for STN DBS as part of their regular medical care; present complications due to drug use such as dyskinesias, refractory tremor or a decrease in quality of life on/off medication; show willingness and ability to return for study visits at the initial programming stage (and after three, six and twelve months); have a FOG-Q score ≥1 or MDS-UPDRS III gait sub-score ≥ 1."
Answered by AI
What is the current enrollment rate for this research program?
"Correct. Clinicaltrials.gov reflects that this research project, initially published on October 28th 2019 and most recently revised on October 14th 2022, has opened up its recruitment process for 14 patients from a single facility."
Answered by AI
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