Electric Field Stimulation for Epilepsy

(EE-DES-TIEF Trial)

Enrolling by invitation at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called temporally-interfering electric field stimulation (TIEFS) to determine its effectiveness in treating epilepsy, a condition characterized by recurrent seizures. Researchers aim to understand how TIEFS affects specific epilepsy markers in the brain, particularly in individuals with medial temporal lobe epilepsy. They also examine how this treatment alters brain activity and connections. Individuals undergoing invasive brain monitoring (intracranial EEG studies) might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Do I need to stop my current medications for this epilepsy trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this electric field stimulation is safe for epilepsy patients?

Research has shown that temporally-interfering electric field stimulation (TIEFS) is generally safe and well-tolerated in people. Studies have found that a similar method, TI-tACS, does not cause major neurological or psychological side effects. Another study demonstrated that high-current TI electrical stimulation is both safe and effective. Importantly, this technique can target specific brain areas, such as the hippocampus, without causing harm. These findings suggest that TIEFS should be safe for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for epilepsy, like anticonvulsant drugs and sometimes surgery, work by dampening the brain's electrical activity to prevent seizures. But Temporally Interfering Electric Field Stimulation works differently, using a non-invasive technique to target specific brain areas with electric fields. This method aims to disrupt the abnormal electrical activity that causes seizures without the need for medication or surgery. Researchers are excited because this could offer a new way to control seizures with potentially fewer side effects and without the invasiveness of current options.

What evidence suggests that temporally-interfering electric field stimulation is effective for epilepsy?

Research has shown that a new method called temporally-interfering electric field stimulation (TIEFS), which participants in this trial will receive, might help treat epilepsy. Studies have found that this type of stimulation can focus on specific parts of the brain, such as the hippocampus, which often plays a role in seizures. Evidence suggests that TIEFS can reduce seizure activity by targeting the exact areas where seizures begin. Early findings also indicate that it is safe and well-tolerated in people, which is crucial for any new treatment. While more research is needed, these early results are promising for those with epilepsy. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for individuals with medial temporal lobe epilepsy. Specific details about who can join are not provided, but typically participants must meet certain health criteria and may need to have a specific form of the condition being studied.

Inclusion Criteria

I am undergoing a brain EEG study that involves inserting electrodes.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Patient-specific electric field modeling to determine TIEFS electrode placement

6-10 days post-implantation

Treatment

Participants undergo two sessions of TIEFS, one sham and one active

2 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in epilepsy biomarkers and safety

7-14 days

What Are the Treatments Tested in This Trial?

Interventions

• Temporally Interfering Electric Field Stimulation

Trial Overview

The study is examining temporally-interfering electric field stimulation (TIEFS) as a treatment for epilepsy. It looks at how TIEFS affects epilepsy biomarkers and brain activity in patients, using both within-subject and between-subjects comparisons.

How Is the Trial Designed?

Group I: Temporally-Interfering Electrical Field Central Nervous System Stimulation Experimental Treatment 1 Intervention

Participants in this arm receive temporally-interfering electric fields stimulation.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

St. Anne's University Hospital Brno, Czech Republic

Collaborator

Trials

37

Recruited

9,900+

Semmelweis University

Collaborator

Trials

125

Recruited

51,100+

Hôpital de la Timone (MARSEILLE)

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

This study measured cranial electrical stimulation (CES) effects in 21 epilepsy patients (16 adults and 5 children) using implanted electrodes, finding a strong correlation between measured and predicted electric fields in the brain, indicating the reliability of personalized simulation models.

The results showed that while increasing stimulation intensity raised voltage levels, the frequency of stimulation did not significantly affect the electric fields, and the arrangement of electrodes was crucial for effective stimulation, highlighting the importance of individualized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo Measurements of Electric Fields During Cranial Electrical Stimulation in the Human Brain. Wang, M., Feng, T., Jiang, H., et al.[2022]

The PIMIDES trial focuses on patient-individualized transcranial electric neurostimulation for patients with epilepsy who have a predominant epileptic focus and are resistant to at least two antiepileptic drugs.

This prospective and unblinded study aims to evaluate the safety of subgaleal implantation and the effectiveness of transcranial stimulation in treating pharmacoresistant epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PIMIDES I: a pilot study to assess the feasibility of patient-controlled neurostimulation with the EASEE® system to treat medically refractory focal epilepsy. Kravalis, K., Schulze-Bonhage, A.[2020]

Open-loop electrical cortical stimulation significantly improved seizure control in patients with refractory focal epilepsy, showing a mean reduction of 61% at 1 year, 68% at 2 years, and 80% at 3-7 years post-implantation based on a retrospective study of six patients.

The stimulation was particularly effective in stopping status epilepticus immediately in three patients, leading to long-term seizure reductions of over 90%, with no major procedure-related complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical cortical stimulation for refractory focal epilepsy: A long-term follow-up study. Chang, CW., Lee, ST., Lim, SN., et al.[2019]

Intracranial stimulation has been shown to be a safe adjunctive treatment for adults with medically intractable epilepsy, providing proof of principle in clinical studies.

Different stimulation approaches, including both open-loop and closed-loop systems, are being explored, with closed-loop stimulation showing promise by responding to detected epileptiform activity, potentially enhancing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial stimulation therapy for epilepsy. Skarpaas, TL., Morrell, MJ.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06716866

NCT06716866 | Temporally Interfering Electric Field ...

This study investigates the potential for temporally-interfering electric field stimulation (TIEFS) to treat epilepsy.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11638170/

The safety and efficacy of applying a high-current temporal ...

This study aimed to introduce a high-current TI electrical stimulation protocol to enhance its intensity and evaluate its safety and efficacy

3.

aesnet.org

aesnet.org/abstractslisting/evaluating-the-effectiveness-of-temporal-interference-stimulation-in-decreasing-epileptic-spiking-activity-particularly-when-targeting-the-seizure-onset-zone

Abstracts - American Epilepsy Society

We aimed to investigate the effectiveness of this protocol in patients with temporal lobe epilepsy and compare it with a TI stimulation in the putative seizure ...

4.

nature.com

nature.com/articles/s41593-023-01456-8

Non-invasive temporal interference electrical stimulation of ...

We demonstrate the safety and tolerability of TI stimulation in humans, the ability to focally target the stimulation locus to the hippocampus, ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1935861X24000299

Temporally interfering electric fields brain stimulation in ...

In the present study, TI stimulation was proved to stimulating noninvasively primary motor cortex (M1) of mice, and that TI stimulation with an envelope wave ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9496688/

Safety Evaluation of Employing Temporal Interference ...

These results support that TI-tACS is safe and tolerable in terms of neurological and neuropsychological functions and adverse effects for use ...

7.

frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1484593/full

The safety and efficacy of applying a high-current temporal ...

This study aimed to introduce a high-current TI electrical stimulation protocol to enhance its intensity and evaluate its safety and efficacy