Health TrialsbyHealthPanel

Lily's Grace Temporal Interference

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Wisconsin, Madison

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • TES-TI

    Device

    Real stimulation will take place on visits 2 - 5 or visits 6 - 10.

  • Sham Stimulation

    Other intervention

    Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.

  • Structural and Functional MRI

    Other intervention

    After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Sham Stimulation then Real StimulationExperimental treatment 3 interventions
Group B: Real Stimulation then Sham StimulationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
measured during 8 overnight visits, data collected up to 24 months on study
2

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.

Time frame
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
3

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.

Time frame
measured during 8 overnight visits, data collected up to 24 months on study
4

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.

Time frame
measured during 8 overnight visits, data collected up to 24 months on study

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Lily's Fund for Epilepsy Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: