Health TrialsbyHealthPanel

CnF-DBS for Levodopa-Resistant FOG

ConditionFreezing of Gait Symptoms in Parkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorIahn Cajigas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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).

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Active StimulationExperimental treatment 1 intervention
Group B: Control (Sham or Sub-Therapeutic) StimulationSham comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iahn Cajigas

Lead sponsor

University of Pennsylvania

Sponsor institution

University of Miami

Collaborator

University of California, San Francisco

Collaborator

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: