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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04770337
• Other study ID #: NE001
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Neuroelectrics Corporation
• Contact: Julia Casanovas, Engineer
• Phone: 34 93 254 03 66
• Email: julia.casanovas[@]neuroelectrics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study design is an evaluation of the STARSTIM device (tDCS) in subjects over 9 years of age, diagnosed with epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures. Seizure diaries will be collected for 12 weeks to establish a rate of seizure for each subject prior to treatment. 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. Treatment will be done daily at the investigator's site for 10 days. A Seizure Diary will be maintained through the course of the treatment and the follow up period. Subjects will have 3 follow up visits to evaluate their seizure rate, adverse events, medications and quality of life. A Data Safety Monitoring Board will be utilized to evaluate safety events through study milestones. Seizure frequency rates pre, during and post treatment will be evaluated for both the active and sham treatment arms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion 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.

Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsies, Partial
• Epilepsy
• Epilepsy in Children
• Epilepsy, Generalized
• Epilepsy, Tonic-Clonic
• Focal Seizure
• Refractory Epilepsy
• Seizures
• Seizures, Focal

Intervention

Device:
• STARSTIM 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.
• Sham Device
Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Ghent University Hospital	Ghent
France	Hospices Civils De Lyon	Lyon
France	CHU de Marseille - Hôpital de la Timone	Marseille
Spain	Hospital Universitario Albacete	Albacete
Spain	HM Nou Delfos	Barcelona
Spain	Hospital Clínic	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Sant Joan de Déu	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Niño Jesús	Madrid
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario Regional de Málaga	Málaga
Spain	Centro de Neurología Avanzada	Sevilla
United States	Johns Hopkins University	Baltimore	Maryland
United States	Sinai Hospital	Baltimore	Maryland
United States	Beth Israel Deconess Medical Center	Boston	Massachusetts
United States	Boston Children's Hospital Comprehensive Epilepsy Center	Boston	Massachusetts
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	Loma Linda University Health	Loma Linda	California
United States	Keck Medicine of USC	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Robert Wood Johnson Medical School (Rutgers)	New Brunswick	New Jersey
United States	Children's Hospital of Orange County	Orange	California
United States	University of Pennsylvania (Penn Epilepsy)	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute, St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Washington University Medical Center	Saint Louis	Missouri
United States	University Of Utah	Salt Lake City	Utah
United States	Seattle Children's Hospital, University of Washington	Seattle	Washington
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Neuroelectrics Corporation

Countries where clinical trial is conducted

United States,  Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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