RNS System Feasibility Study of Thalamocortical Brain-Responsive Neurostimulation for the Treatment of Lennox-Gastaut Syndrome

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Participant is 15 years of age or older for first cohort; 12 years of age or older for second cohort. Note that age requirements for eligibility differ by cohort, as follows: the age limit for Cohort 1 is 15 years of age and above and the age limit for Cohort 2 may decrease to 12 years, pending a DSMB letter of recommendation, based on review of interim data analysis and concurrence with NINDS.

• Participant has medically intractable epilepsy defined as failure to achieve acceptable seizure control without unacceptable medication related side effects despite trials of 2 or more antiseizure medications.

• Participant had an average of ≥ 5 drop seizures per month in the 2 months preceding enrollment. A drop seizure is defined as an epileptic seizure (atonic, tonic, tonic-clonic, or myoclonic) involving the entire body, trunk, or head that leads or could lead to a fall, injury, or slumping in a chair.

• Participant's seizures are non-localized.

• Participant's scalp recorded EEG has features of LGS, such as multifocal spike, slow spike and wave discharges, and paroxysmal fast activity.

• Participant must (a) have a stable antiseizure medication (ASM) regimen for the 2 months preceding enrollment and (b) be willing to remain on the stable regimen, as medically able, through the Blinded Evaluation Period; rescue medication for acute seizure clusters are permitted. A stable ASM regimen is defined as no introduction or discontinuation of an ASM, and no change in an ASM dose of more than 25%.

• Participant is not on a therapeutic diet for epilepsy, or if participant is on a therapeutic diet for epilepsy must (a) have a stable diet for the 2 months preceding enrollment and (b) be willing to remain on the stable diet, as medically able, through the Blinded Evaluation Period.

• Participant does not have a vagus nerve stimulator (VNS), or if participant does have a VNS must (a) have had the VNS off for the 2 months preceding enrollment and (b) be willing to remain with the VNS off through the Blinded Evaluation Period.

• Participant is a male, or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).

• Participant is willing to give informed consent (or assent, if a minor); if the participant assents or is not able to give informed consent, parent/legal guardian is willing to give informed consent.

• Participant is able to maintain a seizure log alone or with the assistance of a competent individual.

• Participant is able to attend study appointments in accordance with the study schedule.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of California, San Francisco
RECRUITING
San Francisco
Georgia
Emory University
RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
New York
Mount Sinai Hospital
RECRUITING
New York
NYU Langone Medical Center
RECRUITING
New York
Contact Information
Primary
Tricia Cunningham
tcunningham@neuropace.com
831-854-3585
Backup
Julie Harvey Park
jpark@neuropace.com
650-279-8599
Time Frame
Start Date: 2022-10-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 24
Treatments
Active_comparator: Condition A
high-frequency short bursts (HFSB: 100 Hz, 160 µs pulse width, 200 msec burst)
Active_comparator: Condition B
low-frequency long bursts (LFLB: 5 Hz, 160 µs pulse width, 5 sec burst)
Sponsors
Collaborators: University of Florida, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: NeuroPace

This content was sourced from clinicaltrials.gov

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