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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH | NRL Neurology | Other Identifier | UW Madison | |
| Protocol Version 2/17/26 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Lily's Fund for Epilepsy Research | UNKNOWN |
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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) wherein they are presented with positive, negative, or neutral emotional stimuli.
This is followed by a resting HD-EEG recording, then overnight stimulation. Either sham or non-sham (8 patients in each group) stimuli will be applied at times during the sleep period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation then Real Stimulation | Experimental | Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions. |
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| Real Stimulation then Sham Stimulation | Experimental | Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TES-TI | Device | Real stimulation will take place on visits 2 - 5 or visits 6 - 10. |
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| Measure | Description | Time Frame |
|---|---|---|
| NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power) | To assess the effect of TES-TI on NREM sleep slow-wave activity during treatment (4 nights) vs. sham (4 nights), slow-wave activity will be measured by high-density EEG. | measured during 8 overnight visits, data collected up to 24 months on study |
| Number of Seizures per week | To assess the effect of TES-TI on incidence of seizures after treatment (4 nights) vs. sham (4 nights), participants will maintain a seizure diary. The self-reported number of seizures seizures per week for the first week and the first four-weeks post-intervention. | data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition |
| Psychomotor Vigilance Task (PVT) | The vigilance task will be used to assess the effect of TES-TI on performance after treatment (4 nights) vs. sham (4 nights). This is a computerized reaction time task where a participant is presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The time it took to respond is recorded automatically by the computer program and will be reported as the result. | measured during 8 overnight visits, data collected up to 24 months on study |
| Restorative Sleep Questionnaire (REST-Q) | The REST-Q measure will be used to assess the effect of TES-TI on sleep quality and mood after treatment (4 nights) vs. sham (4 nights). It is a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale (1-light; 5-deep). Final scores are transformed to a scale of 0-100 here higher scores indicate more restorative sleep. | measured during 8 overnight visits, data collected up to 24 months on study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie Boly, MD, PhD | Contact | 608-263-4338 | boly@neurology.wisc.edu | |
| Beril Mat, MD | Contact | mat@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melanie Boly, MD, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham Stimulation | Other | Sham stimulation will take place on visits 2 - 5 or visits 6 - 10. |
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| Structural and Functional MRI | Other | After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement. |
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| Stanford Sleepiness Scale (SSS) | The Stanford Sleepiness Scale will be used to assess sleepiness after treatment (4 nights) vs. sham (4 nights). SSS is a measure of subjective alertness on a 7-point scale (total range of scores from 1-7). A lower score on the scale indicates higher alertness. | measured during 8 overnight visits, data collected up to 24 months on study |
| Emotional Processing Task (Face Task): Percent Correct | The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). | measured during 8 overnight visits, data collected up to 24 months on study |
| Emotional Processing Task (Face Task): Percent Change in Reaction Time | The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). | measured during 8 overnight visits, data collected up to 24 months on study |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |