RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY

Quick Facts

Study Start:2021-10-25

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04770337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 9 years old or older 2. 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. 3. 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. 4. Seizure frequency ≥3 per month, over the past year. 5. Currently on ≥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. 6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure. 7. 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). 8. Available seizure history and supporting data 9. All female study subjects of child-bearing 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). 10. Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study. 11. Assent from pediatric subjects when appropriate.	1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data. 2. 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 subject's seizures. 3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal 4. Seizure focus is hemispheric or poorly defined 5. History of psychogenic nonepileptic 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 subject's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the subject's PNES compared to their epileptic seizures. 6. Seizures of generalized onset 7. Status epilepticus in the last 12 months 8. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the subject's ability to complete a study of 24 weeks duration 9. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data. 10. Damaged skin on scalp that may interfere with tDCS stimulation. 11. Pregnant or unwilling to practice birth control during participation in the study. 12. Nursing mothers. 13. 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. 14. 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. 15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.

Inclusion Criteria

Exclusion Criteria

1. 9 years old or older
2. 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.
3. 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.
4. Seizure frequency ≥3 per month, over the past year.
5. Currently on ≥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.
6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure.
7. 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).
8. Available seizure history and supporting data
9. All female study subjects of child-bearing 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).
10. Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study.
11. Assent from pediatric subjects when appropriate.

1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data.
2. 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 subject's seizures.
3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal
4. Seizure focus is hemispheric or poorly defined
5. History of psychogenic nonepileptic 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 subject's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the subject's PNES compared to their epileptic seizures.
6. Seizures of generalized onset
7. Status epilepticus in the last 12 months
8. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the subject's ability to complete a study of 24 weeks duration
9. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data.
10. Damaged skin on scalp that may interfere with tDCS stimulation.
11. Pregnant or unwilling to practice birth control during participation in the study.
12. Nursing mothers.
13. 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.
14. 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.
15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.

Contacts and Locations

Study Contact

Julia Casanovas, Engineer

CONTACT

34 93 254 03 66

julia.casanovas@neuroelectrics.com

Thaïs Baleeiro, PhD

CONTACT

34 93 254 03 66

thais.baleeiro@neuroelectrics.com

Study Locations (Sites)

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

Phoenix, Arizona, 85013

United States

Loma Linda University Health

Loma Linda, California, 92354

United States

Keck Medicine of USC

Los Angeles, California, 90033

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

University of Florida Jacksonville

Jacksonville, Florida, 32209

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Sinai Hospital

Baltimore, Maryland, 21215

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Boston Children's Hospital Comprehensive Epilepsy Center

Boston, Massachusetts, 02115

United States

Beth Israel Deconess Medical Center

Boston, Massachusetts, 02215

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Washington University Medical Center

Saint Louis, Missouri, 63110

United States

Robert Wood Johnson Medical School (Rutgers)

New Brunswick, New Jersey, 08901

United States

University of Rochester

Rochester, New York, 14642

United States

University of Pennsylvania (Penn Epilepsy)

Philadelphia, Pennsylvania, 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

United States

University Of Utah

Salt Lake City, Utah, 84132

United States

Seattle Children's Hospital, University of Washington

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Neuroelectrics Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-25

Study Completion Date2026-07

Study Record Updates

Study Start Date2021-10-25

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Epilepsy
Focal seizure
Seizure

Additional Relevant MeSH Terms

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