Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06819020
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-24
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptive Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease
Sponsor:
Doris Wang, MD, PhD
Organization:
Study Overview
Official Title:
Adaptive Deep Brain Stimulation to Improve Freezing of Gait in Parkinson's Disease Using Percept RC
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.
Detailed Description:
The main questions it aims to answer are:
1. Does adaptive DBS lead to fewer freezing of gait episodes for participants compared to their clinical continuous DBS settings?
2. Does adaptive DBS change other parts of participants' walking, like step length, step time, or step symmetry?
Investigators will compare personalized adaptive DBS settings for each participant with their continuous DBS settings to see if adaptive DBS works better to treat gait symptoms, including freezing of gait.
Participants will have DBS insertion surgery as part of their standard medical care. Along with the DBS system, they will also have permanent sensors placed between their skull and scalp to detect brain activity related to movement. After, participants will:
1. Measure their walking using at-home monitoring devices (worn on the hip or ankles) while on their clinical continuous DBS settings.
2. Visit the lab for check-ins and testing of adaptive DBS settings.
3. Try different adaptive DBS settings at home, while wearing at-home monitoring devices.
1. Does adaptive DBS lead to fewer freezing of gait episodes for participants compared to their clinical continuous DBS settings?
2. Does adaptive DBS change other parts of participants' walking, like step length, step time, or step symmetry?
Investigators will compare personalized adaptive DBS settings for each participant with their continuous DBS settings to see if adaptive DBS works better to treat gait symptoms, including freezing of gait.
Participants will have DBS insertion surgery as part of their standard medical care. Along with the DBS system, they will also have permanent sensors placed between their skull and scalp to detect brain activity related to movement. After, participants will:
1. Measure their walking using at-home monitoring devices (worn on the hip or ankles) while on their clinical continuous DBS settings.
2. Visit the lab for check-ins and testing of adaptive DBS settings.
3. Try different adaptive DBS settings at home, while wearing at-home monitoring devices.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: