Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy (NCT04770337) | Clinical Trial Compass
CompletedNot Applicable
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
United States127 participantsStarted 2021-10-25
Plain-language 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.
Who can participate
Age range9 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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).
What they're measuring
1
The difference between active treatment and sham treatment in the percentage change
Timeframe: from baseline in seizures over the 12 weeks following initiation of treatment.
✓. Available seizure history and supporting data
Exclusion criteria
✕. 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).