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Refractory EpilepsyNCT04770337

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

A study testing STARSTIM device in people with Refractory Epilepsy and Focal Seizure, run by Neuroelectrics Corporation at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 9 years and older
What is being tested?
STARSTIM device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
32 sitesin 4 countries
Study dates
25 Oct 2021to 12 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 9 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Participation in an interventional clinical trial within 30 days prior to screening.
  • Patient's head circumference > 64 cm

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States18 sites

  • Sinai Hospital

    Baltimore, Maryland, 21215

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Boston Children's Hospital Comprehensive Epilepsy Center

    Boston, Massachusetts, 02115

  • Beth Israel Deconess Medical Center

    Boston, Massachusetts, 02215

  • University of Florida Jacksonville

    Jacksonville, Florida, 32209

  • Loma Linda University Health

    Loma Linda, California, 92354

  • Keck Medicine of USC

    Los Angeles, California, 90033

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Robert Wood Johnson Medical School (Rutgers)

    New Brunswick, New Jersey, 08901

  • Children's Hospital of Orange County

    Orange, California, 92868

  • University of Pennsylvania (Penn Epilepsy)

    Philadelphia, Pennsylvania, 19104

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

    Phoenix, Arizona, 85013

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • University Of Utah

    Salt Lake City, Utah, 84132

  • Seattle Children's Hospital, University of Washington

    Seattle, Washington, 98105

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Washington University Medical Center

    St Louis, Missouri, 63110

Other trials in United States

Spain10 sites

  • Hospital Universitario Albacete

    Albacete

  • HM Nou Delfos

    Barcelona

  • Hospital Clínic

    Barcelona

  • Hospital Del Mar

    Barcelona

  • Hospital Sant Joan de Déu

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Niño Jesús

    Madrid

  • Hospital Ruber Internacional

    Madrid

  • Hospital Universitario Regional de Málaga

    Málaga

  • Centro de Neurología Avanzada

    Seville

Other trials in Spain

Belgium2 sites

  • Cliniques Universitaires Saint Luc

    Brussels

  • Ghent University Hospital

    Ghent

Other trials in Belgium

France2 sites

  • Hospices Civils De Lyon

    Lyon

  • CHU de Marseille - Hôpital de la Timone

    Marseille

Other trials in France

About this study

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

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.

Read the detailed 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.

Being tested
STARSTIM device, Sham Device
Keywords
Epilepsy, Focal seizure, Seizure
Medical subject headings
Drug Resistant Epilepsy, Seizures, Epilepsy, Epilepsy, Tonic-Clonic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STARSTIM deviceDevice

    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 DeviceDevice

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

Study groups in NCT04770337
Study groupRoleWhat they receive
Sham treatmentSham comparatorSubjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Receives: Device: Sham Device
STARSTIM device treatmentExperimentalSubjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Receives: Device: STARSTIM device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference between active treatment and sham treatment in the percentage change

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

Secondary outcomes (1)

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

    Measured: from baseline to week 12 post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2021
  2. Study start25 Oct 2021
  3. Primary completion12 Jan 2026
  4. Study completion12 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multiple site, randomized, double blinded parallel-group controlled study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04770337
Sponsor's protocol ID
NE001
Status last verified
Apr 2026
First submitted
22 Feb 2021
Last updated
8 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing STARSTIM device in people with Refractory Epilepsy and Focal Seizure, run by Neuroelectrics Corporation at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference between active treatment and sham treatment in the percentage change (time frame: from baseline in seizures over the 12 weeks following initiation of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04770337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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