Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

NCT04770337 | Completed FDA Device

• 1 other identifier: NE001
• Study Type: interventional
• Target: 127
• Locations: 4 countries
• Sites: 32

Brief Summary

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Conditions

Seizures; Epilepsy in Children; Epilepsy; Epilepsy, Tonic-Clonic; Refractory Epilepsy; Focal Seizure; Seizures, Focal

Keywords

Epilepsy; Focal seizure; Seizure

Outcome Measures

Primary Outcomes (1)

• The difference between active treatment and sham treatment in the percentage change

  from baseline in seizures over the 12 weeks following initiation of treatment.

Secondary Outcomes (1)

• The proportion of subjects who are responders (defined as subjects with a 50% or greater reduction in seizure frequency

  from baseline to week 12 post-treatment

Study Arms (2)

Sham treatment

SHAM COMPARATOR

Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.

Device: Sham Device

STARSTIM device treatment

EXPERIMENTAL

Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.

Device: STARSTIM device

Interventions

STARSTIM device DEVICE

Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.

STARSTIM device treatment

Sham Device DEVICE

Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp

Sham treatment

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older.
• Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic-clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures.
• Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.
• Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years.
• Seizure frequency average of ≥3 per month, over the past year.
• Currently on at least 1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary.
• An MRI scan of the brain using a 1.5 Tesla magnet, or greater, with T1, T2 (recommended), and FLAIR sequences, acquired within the last 3 years for children (patients \<18 years old), or within 5 years for adult patients ≥18 years old, as long as the MRI was obtained after the onset of epilepsy and without brain surgeries after the MRI images.
• Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri).
• Available seizure history and supporting data
• All female study subjects of childbearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of \<=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective).
• Written informed consent obtained from study patient or patient's legal representative and ability for study patient to comply with the requirements of the study.
• Assent from pediatric patients when appropriate.

You may not qualify if:

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the integrity of the data.
• Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise, as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology). If the interictal EEG is normal, a seizure focus may be identified by the combination of structural findings on MRI and clinical signs/symptoms associated with the patient's seizures.
• Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal
• Seizure focus is hemispheric or poorly defined
• History of psychogenic non-epileptic seizures in past 2 years, or physiologic nonepileptic seizures and non-epileptogenic events, including suspicion for or a significant history of syncope, and any non-epileptic events must be clearly differentiable from patient's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the patient's psychogenic non-epileptic seizures (PNES) compared to their epileptic seizures.
• Seizures of generalized onset
• Status epilepticus in the last 12 months
• Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the patient's ability to complete a study duration of 28 weeks (4 weeks screening, 12 weeks baseline, 2 weeks tDCS, 10 weeks follow-up).
• Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the patient or the integrity of the data.
• Damaged skin on scalp that may interfere with tDCS stimulation.
• Pregnant or unwilling to practice birth control during participation in the study.
• Nursing mothers.
• Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e., cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Note: Vagus nerve stimulator (VNS) is allowable if the device is in MR Mode (e.g., switched off) during tDCS stimulation and the VNS device is MR conditional.
• Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
• Substance use disorder (including alcohol) according to Diagnostic and Statistical Manual, 5th edition (DSM-V) criteria in the past 3 years.

Sponsors & Collaborators

• Neuroelectrics Corporation: lead

Study Sites (32)

Barrow Neurological Institute, St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Keck Medicine of USC

Los Angeles, California, 90033, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital Comprehensive Epilepsy Center

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Robert Wood Johnson Medical School (Rutgers)

New Brunswick, New Jersey, 08901, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of Pennsylvania (Penn Epilepsy)

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University Of Utah

Salt Lake City, Utah, 84132, United States

Location

Seattle Children's Hospital, University of Washington

Seattle, Washington, 98105, United States

Location

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Hospices Civils De Lyon

Lyon, France

Location

CHU de Marseille - Hôpital de la Timone

Marseille, France

Location

Hospital Universitario Albacete

Albacete, Spain

Location

HM Nou Delfos

Barcelona, Spain

Location

Hospital Clínic

Barcelona, Spain

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital Sant Joan de Déu

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Niño Jesús

Madrid, Spain

Location

Hospital Ruber Internacional

Madrid, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, Spain

Location

Centro de Neurología Avanzada

Seville, Spain

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Seizures; Epilepsy; Epilepsy, Tonic-Clonic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy, Generalized

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multiple site, randomized, double blinded parallel-group controlled study

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: October 25, 2021
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

BE (2); FR (2); ES (10); US (18)