Freezing of Gait Symptoms in Parkinson DiseaseCnF-DBS-FOGNCT07781696
CnF-DBS for Levodopa-Resistant FOG
A study testing Active Stimulation in people with Freezing of Gait Symptoms in Parkinson Disease, run by Iahn Cajigas at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Freezing of Gait Symptoms in Parkinson Disease
- What is being tested?
- Active Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35 and 80 years
- 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)
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Miami
Miami, Florida, 33125
Letitia Fisher, 305-243-3056, lfisher@med.miami.edu
Jonathan Jagid, MD
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
James Mitchell, 215-829-6720, james.mitchell1@pennmedicine.upenn.edu
Neurosurgery Clinical Research Division, 215-829-6720, npn@uphs.upenn.edu
University of California San Francisco (UCSF)
San Francisco, California, 94143
Amanda Sayaseng, 415-307-2325, amanda.sayaseng@ucsf.edu
Doris Wang, MD, PhD
About this study
Official title: Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-Resistant Freezing of Gait in Parkinson's Disease
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.
Read the detailed description
This is a multi-site, prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial assessing the extent to which cuneiform nucleus deep brain stimulation (CnF DBS) can ameliorate freezing of gait (FOG) in Parkinson's Disease (PD) patients with severe, Levodopa-resistant gait freezing. The study intends to determine the optimal stimulation parameters (frequency, pulse, amplitude) that maximize gait performance while minimizing any potential side effects and to evaluate the effect of CnF DBS on other PD symptoms (including pain) and quality of life.
Participation in the study is expected to last approximately eight months from enrollment through completion of study activities. 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.
The most significant risks of participation are those associated with DBS surgery and chronic brain stimulation, including bleeding, infection, stroke, seizure, device-related complications, worsening of neurological symptoms, falls, and stimulation-related side effects.
- Being tested
- Active Stimulation, Sham (No Treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active StimulationDevice
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
Also called Control, Sub-Therapeutic
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 group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Not described Receives: Device: Active Stimulation |
| Control (Sham or Sub-Therapeutic) Stimulation | Sham comparator | Not described Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) Time
Change in Timed Up and Go (TUG) time with and without bilateral CnF DBS
Measured: 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
Measured: Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of Gait Symptoms in Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iahn Cajigas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, University of California, San Francisco, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor-investigator, Iahn Cajigas, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781696
- Sponsor's protocol ID
- 26-6081
- Other IDs
- MJFF-026726
- Acronym
- CnF-DBS-FOG
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-Resistant Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07781696
- Acronym / sponsor ID
- CnF-DBS-FOG / 26-6081
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Iahn CajigasUniversity, hospital or other
- Collaborators
- University of Miami, University of California, San Francisco, Michael J. Fox Foundation for Parkinson's Research
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-site, prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial assessing the extent to which cuneiform nucleus deep brain stimulation (CnF DBS) can ameliorate freezing of gait (FOG) in Parkinson's Disease (PD) patients with severe, Levodopa-resistant gait freezing. The study intends to determine the optimal stimulation parameters (frequency, pulse, amplitude) that maximize gait performance while minimizing any potential side effects and to evaluate the effect of CnF DBS on other PD symptoms (including pain) and quality of life.
Participation in the study is expected to last approximately eight months from enrollment through completion of study activities. 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.
The most significant risks of participation are those associated with DBS surgery and chronic brain stimulation, including bleeding, infection, stroke, seizure, device-related complications, worsening of neurological symptoms, falls, and stimulation-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Active Stimulation |
| Control (Sham or Sub-Therapeutic) Stimulation | Sham comparator | Device: Sham (No Treatment) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 35 and 80 years
- 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)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active StimulationActive CnF DBS will be delivered using predefined stimulation parameter ranges considered potentially therapeutic based on prior preclinical and clinical data. | Device | Active Stimulation |
| Sham (No Treatment)Also: Control, Sub-TherapeuticControl (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). | Device | Control (Sham or Sub-Therapeutic) Stimulation |
Primary outcome
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
Change in Timed Up and Go (TUG) time with and without bilateral CnF DBS
Pirouette Test Times
Time frame: Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit
Change in right and left pirouette test times with and without bilateral CnF DBS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of California San Francisco (UCSF)
San Francisco, United States
University of Pennsylvania
Philadelphia, United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Stimulation in people with Freezing of Gait Symptoms in Parkinson Disease, run by Iahn Cajigas at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.