University of Wisconsin, Madison
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.
This is a Phase I randomized, single-blind, cross-over feasibility study comprised of 16 participants. Each participant will undergo structural and functional MRI then complete four nights of TES-TI stimulation and four nights of sham stimulation in counterbalanced order, separated by ≥1 day between visits. Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HD-EEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) where…
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 me…
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.
After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.
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