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CnF-DBS for Levodopa-Resistant FOG

NCT07781696 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Freezing of Gait Symptoms in Parkinson Disease

Interventions

DEVICE

Active Stimulation

Active CnF DBS will be delivered using predefined stimulation parameter ranges considered potentially therapeutic based on prior preclinical and clinical data.

DEVICE

Sham (No Treatment)

Control (sham or sub-therapeutic) stimulation will consist of stimulation settings expected to have no or minimal physiological effect (e.g., stimulation off or amplitude below a predefined threshold).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781696 on ClinicalTrials.gov