CnF-DBS for Levodopa-Resistant FOG

NCT07781696 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 26-6081MJFF-026726
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Timed Up and Go (TUG) Time

  Change in Timed Up and Go (TUG) time with and without bilateral CnF DBS

  Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit

• Pirouette Test Times

  Change in right and left pirouette test times with and without bilateral CnF DBS

  Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit

Study Arms (2)

Active Stimulation

EXPERIMENTAL

Device: Active Stimulation

Control (Sham or Sub-Therapeutic) Stimulation

SHAM COMPARATOR

Device: Sham (No Treatment)

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.

Active Stimulation

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).

Also known as: Control, Sub-Therapeutic

Control (Sham or Sub-Therapeutic) Stimulation

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 35 and 80 years
• Postural Instability and Gait Difficulty (PIGD)-predominant PD, defined by a Tremor-Dominant (TD)/PIGD ratio of ≤ 0.90, as calculated from MDS-UPDRS items, according to previously validated methods46
• FOGQ score of \> 12, consistent with severe gait disorder47-49
• Clinical observation of FOG in ON and/or OFF medication states by a movement disorder neurologist
• FOG refractory to optimized dopaminergic therapy by a movement disorder neurologist
• Minimal tremor, bradykinesia, and rigidity, or well controlled motor symptoms with optimized dopaminergic therapy and/or previously implanted STN or GPi DBS, such that FOG and axial dysfunction represent the predominant disabling motor features
• Adequate cognitive function (e.g., Mattis Dementia Rating Scale-2 (DRS-2) \> 130) and absence of major uncontrolled psychiatric illness (e.g., Beck's Depression Inventory-II (BDI-II) ≤ 25)
• Willingness and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), at the principal investigator's discretion
• Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)
• Willingness and ability to provide informed consent, at the principal investigator's discretion

You may not qualify if:

• Major executive dysfunction or dementia (DRS-2 ≤ 130) or other neurocognitive impairments that would interfere with informed consent or study participation, at the principal investigator's discretion
• Depression, defined, for example, by BDI-II \> 25 or diagnosis of one or more other high-risk psychiatric conditions (e.g., substance use disorder, severe anxiety, uncontrolled bipolar disorder), at the principal investigator's discretion
• Presence of high suicide risk on the Columbia-Suicide Severity Rating Scale (C-SSRS) as defined below Participants will be excluded if they endorse active suicidal ideation with intent to act (C-SSRS Severity Level 4 or 5) during screening, report a suicide attempt, interrupted attempt, or aborted attempt within the previous 6 months, or are determined by the study psychiatrist and/or principal investigator to present clinically significant suicide risk.
• Major medical co-morbidities and other surgical contraindications such as uncontrolled hypertension, severe cardiopulmonary disease, coagulopathy, epilepsy, prior intracranial hemorrhage, or significant cerebrovascular disease, at the principal investigator's discretion
• Need for diathermy, TMS, or ECT during the study
• History of prior intracranial surgery (other than prior STN or GPi DBS for PD) that substantially alters anatomy or risk at the CnF target, at the principal investigator's discretion
• Any metallic implant in the head that is not MRI-compatible (e.g., certain aneurysm clips, cochlear implants)
• Active implantable devices anywhere in the body (e.g. pacemaker, defibrillator, spinal cord stimulator, implanted medication pump) that may affect imaging quality or interact with DBS, unless specifically permitted by device labeling and investigator judgment
• Pregnancy, intent to become pregnant during the study, breastfeeding, or unwillingness to use an acceptable method of contraception throughout the course of the trial
• Current participation in other interventional trials or use of investigational drugs or devices that may influence gait or DBS outcomes, at the principal investigator's discretion

Sponsors & Collaborators

• Iahn Cajigas: lead
• University of California, San Francisco: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• University of Miami: collaborator

Study Sites (3)

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery and Bioengineering

Model Details: prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (3)