ClinicalTrials.gg
Not yet recruitingNCT07781696CnF-DBS-FOGUpdated Nov 12, 2026

CnF-DBS for Levodopa-Resistant FOG

An interventional study of Active Stimulation and Sham (No Treatment) in Freezing of Gait Symptoms in Parkinson Disease, sponsored by Iahn Cajigas. Not yet recruiting at 3 sites in United States. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Iahn Cajigas · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Planned enrollment
918th of 1,256
18 · median 36
Started
2026
with 82 others
No phase
585 of 1,649
146 open now
Primary completion
2028-08
later than 283 of 384 live
Registered
1,630th of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 918th largest by planned enrollment of the 1,256 interventional ones that give a count, is one of 83 that started in 2026, is one of 585 with no phase, reaches primary completion later than 283 of the 384 other live ones, and was the 1,630th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

304 of the 1,649 studies in Parkinson Disease with a site in United States are open now. Recruiting first, the newest first:

299 more — sign in →

All 304 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 35 Years to 80 Years · all sexes · no healthy volunteers.

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02

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.

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.

03

Conditions studied

  • Freezing of Gait Symptoms in Parkinson Disease

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04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 , at the principal investigator's discretion

Exclusion criteria

Exclusion Criteria:

  1. Major executive dysfunction or dementia (DRS-2 ≤ 130) or other neurocognitive impairments that would interfere with 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 suicide risk.
  4. Major medical co-morbidities and other surgical 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 throughout the course of the trial
  10. Current participation in other interventional trials or use of drugs or devices that may influence gait or DBS outcomes, at the principal investigator's discretion
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Active Stimulation

    Device: Active Stimulation

  • Sham comparator
    Control (Sham or Sub-Therapeutic) Stimulation

    Device: Sham (No Treatment)

Interventions

  • DeviceActive Stimulation

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

  • DeviceSham (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).

    Also known as: Control, Sub-Therapeutic

06

What researchers measure

Primary outcomes

  1. Timed Up and Go (TUG) Time

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

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

  2. Pirouette Test Times

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

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

07

Study locations

3 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Aug 2028, 20 months later.

Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 20 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 12, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 24, 2026
StartEst.
Dec 2026was Sep 2026
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 2026→Dec 2026
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Start date Sep 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07781696
Lead sponsor
Iahn Cajigas
Collaborators
University of Miami, University of California, San Francisco, Michael J. Fox Foundation for Parkinson's Research
Responsible party
Iahn Cajigas (Assistant Professor of Neurosurgery and Bioengineering, University of Pennsylvania) — Sponsor-investigator
First posted
Aug 24, 2026
Start date
Dec 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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