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

July 21, 2023 updated by: Neuroelectrics Corporation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bruxelles, Belgium
      • Ghent, Belgium
        • Recruiting
        • Ghent University Hosp. Dpt Neurology
        • Contact:
  • France
  • Spain
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute, St. Joseph's Hospital & Medical Center
        • Contact:
          • Susan Herman, M.D
        • Contact:
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health
        • Contact:
          • Firas Bannout, M.D
        • Contact:
          • David Borg, CRC
          • Phone Number: (909) 558-2037
          • Email: dborg@llu.edu
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medicine of USC
        • Contact:
        • Contact:
          • Charles Liu, M.D
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
          • Donald Phillips, M.D
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Jacksonville
        • Contact:
        • Contact:
          • Katherine Zarroli, M.D
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital
        • Contact:
        • Contact:
          • Arash Foroughi, M.D
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital Comprehensive Epilepsy Center
        • Contact:
        • Contact:
          • Alexander Rotenberg, M.D
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deconess Medical Center
        • Contact:
        • Contact:
          • Mo Shafi, M.D
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
          • Brian Lundstrom, M.D
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Medical Center
        • Contact:
        • Contact:
          • Robert Hogan, M.D
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson Medical School (Rutgers)
        • Contact:
        • Contact:
          • Ram Mani, M.D
    • New York
      • Rochester, New York, United States, 14642
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
          • Abou-Khalil Bassel, M.D
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Contact:
          • Amir Arain, M.D
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital, University of Washington
        • Contact:
        • Contact:
          • Xiuhua Bozarth, M.D

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.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Device: Sham Device
Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp
Experimental: STARSTIM device treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
from baseline in seizures over the 12 weeks following initiation of treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects who are responders (defined as subjects with a 50% or greater reduction in seizure frequency
Time Frame: from baseline to week 12 post-treatment
from baseline to week 12 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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