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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
Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1st screening visit through day 61 (day 60 ± 8) follow-up visit.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on the best dose of Parkinson's medication as decided by my neurologist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st screening visit through day 61 (day 60 ± 8) follow-up visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1st screening visit through day 61 (day 60 ± 8) follow-up visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Objective
Secondary outcome measures
Secondary Efficacy Endpoint
Other outcome measures
Safety Endpoints

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.

Find a Location

Who is running the clinical trial?

CereGate Inc.Lead Sponsor
Brian BlischakStudy ChairCereGate Inc.

Media Library

CereGate Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05292794 — N/A
Parkinson's Disease Research Study Groups: PD Patients treated with CereGate Software
Parkinson's Disease Clinical Trial 2023: CereGate Therapy Highlights & Side Effects. Trial Name: NCT05292794 — N/A
CereGate Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05292794 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall participant count for this investigation?

"The clinical trial necessitates the enrollment of 41 suitable candidates. Participants may register at Kaiser Permanente, KPNC Comprehensive Movement Disorders Program in Redwood City, California or Cedars Sinai Neurology in Los Angeles, Colorado."

Answered by AI

Is the age cutoff for this trial restrictive to those over 50?

"This study requires that all participants be aged between 21 and 75. Concerning younger or older individuals, there are 27 trials for minors and 496 studies specifically recruiting seniors."

Answered by AI

Are there any US-based healthcare institutions that are currently trialing this?

"The study is being run by 4 key organisations: Kaiser Permanente, KPNC Comprehensive Movement Disorders Program in Redwood City, Cedars Sinai Neurology in Los Angeles and University of Colorado Anschutz Medical Campus in Aurora. Additionally, there are other sites carrying out the trial at different locations."

Answered by AI

Might I have the opportunity to join this clinical experiment?

"This medical research is aiming to acquire 41 participants aged 21-75 with a current diagnosis of Parkinson's disease. Other prerequisites for participation include; evidence of successful Boston Scientific Gevia STN-DBS implantation, therapeutic use of Carbidopa/Levodopa and dopamine agonists monitored by a movement disorders neurologist, plus improved motor signs (UPDRSIII) from Deep Brain Stimulation optimization."

Answered by AI

Are there currently any opportunities to join this trial?

"Indeed, the clinical trial is still open to participants. The first posting was on 18 April 2022 and its most recent update took place on 15 November 2022, as per information found on clinicaltrials.gov"

Answered by AI

Who else is applying?

What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. University of Washington: < 48 hours
~11 spots leftby Dec 2024