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Behavioural Intervention
CereGate Therapy for Freezing of Gait in PD
N/A
Recruiting
Research Sponsored by CereGate Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1st screening visit through day 61 (day 60 visit +1-8d) follow-up visit.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a new therapy can help people with Parkinson's disease who have freezing of gait.
Who is the study for?
This trial is for Parkinson's Disease patients with Freezing of Gait who have an implanted Boston Scientific Gevia STN-DBS system and are on stable doses of Parkinson's medications. They must be adults between 21-75 years old, not severely cognitively impaired, and able to follow the study plan.
What is being tested?
The CereGate Therapy is being tested in this controlled study to see if it can help reduce Freezing of Gait in Parkinson’s patients. It involves using specific software and programmers designed to work with their existing DBS systems.
What are the potential side effects?
Potential side effects aren't specified here but may include typical risks associated with deep brain stimulation adjustments such as mood changes, headaches, dizziness or worsening motor symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1st screening visit through day 61 (day 60 visit +1-8d) follow-up visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st screening visit through day 61 (day 60 visit +1-8d) follow-up visit.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy Objective
Secondary study objectives
Secondary Efficacy Endpoint
Other study objectives
Safety Endpoints
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PD Patients treated with CereGate SoftwareExperimental Treatment1 Intervention
This singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand.
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Who is running the clinical trial?
CereGate Inc.Lead Sponsor
Brian BlischakStudy ChairCereGate Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had deep brain stimulation (DBS) treatment and it has improved your motor skills, as shown in documentation.I am willing and able to follow the study's schedule and procedures.I understand the study and can give my consent.I am in the most advanced stage of Parkinson's disease and need help moving around.I have a history of seizures that happen without warning.I have a Boston Scientific Gevia STN-DBS system implanted.I am a woman who could be pregnant, am pregnant, or am breastfeeding and not using strong birth control.My DBS settings have been unchanged for less than 28 days before starting CG.I am either younger than 21 or older than 75.I have a condition that affects my ability to walk.My heart rhythm irregularity is less than 8% before starting CG therapy.I experience uncontrollable movements.I have had thoughts of harming myself or attempted suicide.I did not feel distinct sensations on both sides during the STN stimulation test.My doctor expects I have less than a year to live due to my illness.I am on the best dose of Parkinson's medication as decided by my neurologist.
Research Study Groups:
This trial has the following groups:- Group 1: PD Patients treated with CereGate Software
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.
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