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Deep Brain Stimulation for Freezing of Gait

(CnF-DBS-FOG Trial)

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Iahn Cajigas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this trial is to study the safety, practicality, and effectiveness of deep brain stimulation (DBS) therapy in a brain region called the cuneiform nucleus (CnF) to treat disabling freezing of gait (FOG) in patients with Parkinson's disease (PD) when standard treatments are no longer effective. The study uses either the Medtronic's Percept™ PC or RC systems for DBS therapy. Please note that although the Medtronic systems are FDA-approved for other diseases, they have not been approved for the treatment of FOG in PD and their use for stimulation of the CnF target is experimental.

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who have severe freezing of gait that does not improve with standard medications like levodopa. Participants should be adults and able to undergo surgery, but specific inclusion or exclusion details are not provided.

Inclusion Criteria

I have been observed to have freezing of gait by a movement disorder specialist.
I am willing and able to give informed consent for this study.
FOGQ score > 12 consistent with severe gait disorder
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Exclusion Criteria

Any metallic implant in the head that is not MRI-compatible such as certain aneurysm clips or cochlear implants
I have severe depression or another serious mental health condition.
High suicide risk on Columbia-Suicide Severity Rating Scale including active suicidal ideation with intent, recent suicide attempts within 6 months, or clinically significant suicide risk as determined by study psychiatrist or principal investigator
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What Are the Treatments Tested in This Trial?

Interventions

  • Deep Brain Stimulation (DBS) of Cuneiform Nucleus (CnF)

Trial Overview

The study tests deep brain stimulation (DBS) in a part of the brain called the cuneiform nucleus using Medtronic devices. Some participants will get active DBS, while others receive no stimulation (sham). The goal is to see if DBS helps reduce freezing of gait.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active StimulationExperimental Treatment1 Intervention
Group II: Control (Sham or Sub-Therapeutic) StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Iahn Cajigas

Lead Sponsor

University of Miami

Collaborator

Trials
976
Recruited
423,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials
117
Recruited
537,000+

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