Use of CereGate Therapy for Freezing of Gait in PD

Part of paid clinical trials in Redwood City, California.

Sponsor
CereGate Inc.
Study ID
NCT05292794
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CereGate Software; BSN cDBS Programmer; BSN Burst Programmer — DEVICE
    CereGate's objective is to, with a single DBS system implanted in the standard STN location for PD: (i) deliver conventional tonic DBS stimulation of STN-to mitigate dopamine-responsive symptoms; and concurrently (ii) deliver bursting DBS-induced "cueing" stimulation-to mitigate FOG. The sole function of CereGate Software is to guide the clinician through a systematic investigation of the stimulation parameter space to thereby configure / tune CereGate Therapy for each participant. CereGate Software proposes parameters for the clinician to evaluate and assists in documenting the response. It does not send commands to, nor control the output of, the DBS System.

Study Details

A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.

Key Dates

Start date
Apr 18, 2022
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD Patients treated with CereGate Software
    This singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand.

Primary Outcome Measure

Primary Efficacy Objective [ Time Frame: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Kaiser Permanente, KPNC Comprehensive Movement Disorders ProgramRedwood CityCalifornia94063
Elena Call, MD
[email protected]
650-464-6321
Elena Call, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Drew Kern, MD
[email protected]
303-724-4172
Drew Kern, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Ihtsham Haq, MD
[email protected]
305-243-6732
Lissette Perez
[email protected]
305-243-2172
Ihtsham Haq, MD (PRINCIPAL_INVESTIGATOR)
Corneliu Luca, MD (SUB_INVESTIGATOR)
Taylor Peabody, MD (SUB_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Neil Shetty, MD
[email protected]
312-695-7950
Neil Shetty, MD (PRINCIPAL_INVESTIGATOR)
Joshua Rosenow, MD (SUB_INVESTIGATOR)
Jessica Karl, PhD, PA-C (SUB_INVESTIGATOR)
Wake Forest UniversityWinston-SalemNorth Carolina27157
Tonya Woosley, CRC
[email protected]
336-716-9520
Deepal Shah-Zamora, MD (PRINCIPAL_INVESTIGATOR)
Ha Green, PA (SUB_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Travis J Hassell, M.D.
[email protected]
615-936-2025
Jackie Harris, RMA, CTRC III
[email protected]
615-936-3833
Travis J Harris, M.D. (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Sarah Simon
[email protected]
206-221-2132
Yi-Han (Anny) Lin, MD (PRINCIPAL_INVESTIGATOR)
John Sanderson, MD (SUB_INVESTIGATOR)

Find similar trials in Redwood City, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program· Redwood City, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COUniversity of Miami· Miami, FLNorthwestern University· Chicago, ILWake Forest University· Winston-Salem, NCVanderbilt University Medical Center· Nashville, TN

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