CnF-DBS for Levodopa-Resistant FOG

Part of paid clinical trials in San Francisco, California.

Sponsor
Iahn Cajigas
Study ID
NCT07781696
Status
Not Yet Recruiting

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Conditions

  • Freezing of Gait Symptoms in Parkinson Disease

Eligibility Criteria

Sex
ALL
Age
35 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Stimulation — DEVICE
    Active CnF DBS will be delivered using predefined stimulation parameter ranges considered potentially therapeutic based on prior preclinical and clinical data.
  • Sham (No Treatment) — DEVICE
    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).

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Active Stimulation
  • Sham Comparator: Control (Sham or Sub-Therapeutic) Stimulation

Primary Outcome Measure

Timed Up and Go (TUG) Time [ Time Frame: Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San Francisco (UCSF)San FranciscoCalifornia94143
Amanda Sayaseng
[email protected]
415-307-2325
Doris Wang, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33125
Letitia Fisher
[email protected]
305-243-3056
Jonathan Jagid, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19107
James Mitchell
[email protected]
215-829-6720
Neurosurgery Clinical Research Division
[email protected]
215-829-6720
Iahn Cajigas, MD, PhD (PRINCIPAL_INVESTIGATOR)

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