CnF-DBS for Levodopa-Resistant FOG
Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-Resistant Freezing of Gait in Parkinson's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 35 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Study procedures include medical and neurological evaluations, walking and mobility assessments, questionnaires, brain imaging, device programming visits, and collection of information about your symptoms, safety, and quality of life."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether deep brain stimulation (DBS), which sends electrical signals to the brain, is safe, practical, and helpful for severe freezing of gait—when walking suddenly stops. It is for people with Parkinson’s disease whose freezing does not improve with standard treatment. DBS in the brain area called the cuneiform nucleus is experimental and is not FDA-approved for this use.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 35 to 80 years old.
- Have Parkinson’s disease confirmed by a movement specialist, who has ruled out other causes of walking problems.
- Have Parkinson’s symptoms mainly involving balance and walking, rather than shaking, based on study scores.
- Have severe walking problems, with a Freezing of Gait Questionnaire score above 12.
- Have freezing seen by a movement specialist while on or off medicine, or both, that does not improve with the best medicine treatment.
- Have little shaking, slowness, or stiffness, or have these symptoms well controlled by medicine or earlier DBS. Freezing and body balance problems must be the main movement limits.
- Have enough thinking and memory skills to take part, with no major uncontrolled mental health condition.
- Be willing and able to follow the study schedule, give informed consent, and give written permission for the study team and treating doctors to communicate.
Who can't join
- Have dementia or serious thinking problems that affect consent or participation, depression meeting study limits, or another high-risk mental health condition.
- Have a high suicide risk, including current thoughts with intent to act or a suicide attempt, stopped attempt, or interrupted attempt in the past 6 months.
- Have major health problems that make surgery unsafe, such as uncontrolled high blood pressure, severe heart or lung disease, a blood-clotting problem, seizures, or past bleeding in the brain.
- Need diathermy (deep-heat treatment), TMS (magnetic brain stimulation), or ECT (electrical treatment for mental illness) during the study.
- Have had brain surgery that greatly changes the target area or its risks, other than prior Parkinson’s DBS in areas called the STN or GPi.
- Have metal in the head that is unsafe for MRI scans, or an active implanted device that could interfere with scans or DBS unless specifically allowed.
- Be pregnant, planning pregnancy during the study, breastfeeding, or unwilling to use acceptable birth control throughout the study.
- Be in another treatment trial or use experimental drugs or devices that may affect walking or DBS results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age between 35 and 80 years 2. Confirmed diagnosis of PD, according to a movement disorder neurologist, with documented exclusion of other disorders such as Frontotemporal Dementia (FTD), frontal gait disorder, Normal Pressure Hydrocephalus (NPH), or Progressive Supranuclear Palsy (PSP) 3. 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 4. FOGQ score of \> 12, consistent with severe gait disorder47-49 5. Clinical observation of FOG in ON and/or OFF medication states by a movement disorder neurologist 6. FOG refractory to optimized dopaminergic therapy by a movement disorder neurologist 7. 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 8. 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) 9. 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 10. Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s) 11. Willingness and ability to provide informed consent, at the principal investigator's discretion Exclusion Criteria: 1. 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 2. 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 3. 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. 4. 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 5. Need for diathermy, TMS, or ECT during the study 6. 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 7. Any metallic implant in the head that is not MRI-compatible (e.g., certain aneurysm clips, cochlear implants) 8. 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 9. Pregnancy, intent to become pregnant during the study, breastfeeding, or unwillingness to use an acceptable method of contraception throughout the course of the trial 10. 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
Study sites (3)
CA
- University of California San Francisco (UCSF) · San Francisco, CA 94143Amanda Sayaseng · Study contact · 415-307-2325 · amanda.sayaseng@ucsf.eduDoris Wang, MD, PhD · Principal investigatorMore trials in San Francisco
FL
- University of Miami · Miami, FL 33125Letitia Fisher · Study contact · 305-243-3056 · lfisher@med.miami.eduJonathan Jagid, MD · Principal investigatorMore trials in Miami
PA
- University of Pennsylvania · Philadelphia, PA 19107James Mitchell · Study contact · 215-829-6720 · james.mitchell1@pennmedicine.upenn.eduNeurosurgery Clinical Research Division · Study contact · 215-829-6720 · npn@uphs.upenn.eduIahn Cajigas, MD, PhD · Principal investigatorMore trials in Philadelphia