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NCT07520955
Lily's Grace Temporal Interference
Conditions: Epilepsy
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: University of Wisconsin, Madison
Location: UW School of Medicine and Public Health Madison Wisconsin
Summary
This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) interventions to boost Non-Rapid Eye Movement (NREM) sleep, decrease seizures and promote emotional health in patients with epilepsy. Up to 24 participants (8 control participants for technical optimization prior to recruitment and 16 patients with epilepsy) will be enrolled and can expect to be on study for up to 24 months.
Eligibility Criteria
Inclusion Criteria:
* English-speaking (able to provide consent and complete questionnaires)
* Citizen or holding permanent resident status
* History of refractory epilepsy with intractable seizures and/or cognitive decline
Exclusion Criteria:
* Any current or past history of neurological disorders or acquired neurological disease other than epilepsy (e.g. stroke, traumatic brain injury), including intracranial lesions
* Current history of poorly controlled headaches including intractable or poorly controlled migraines
* Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
* Possible pregnancy or plan to become pregnant in the next 6 months
* Any metal in the head
* Any metal in the body
* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
* Dental implants
* Permanent retainers
* Claustrophobia (a fear of small or closed places)
* Back problems that would prevent lying flat for several hours
* Regular night-shift work (second or third shift)
Source: ClinicalTrials.gov (NCT07520955). StuddyBuddy aggregates publicly available trial information.