Electric Field Stimulation for Epilepsy

(EE-DES-TIEF Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

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

Compensation: Varies

Number of Visits: 2

Duration: 2 days

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Temporally Interfering Electric Field Stimulation for epilepsy?

Research shows that Temporally Interfering Electric Field Stimulation can target specific brain areas without needing implanted electrodes, potentially controlling seizure-like events. This method may overcome limitations of other non-invasive treatments like transcranial magnetic stimulation, suggesting it could be effective for epilepsy. ^{1 2 3 4 5}

Is electric field stimulation safe for humans?

Studies on electric field stimulation for epilepsy, including intracranial and cranial methods, have shown it to be generally safe in humans. These studies have demonstrated the safety of both invasive and non-invasive techniques, with no significant adverse effects reported. ^{2 4 5 6 7}

How does temporally interfering electric field stimulation differ from other epilepsy treatments?

Temporally interfering electric field stimulation is unique because it uses non-invasive surface electrodes to target deep brain regions, unlike traditional methods that require implanted electrodes. This approach allows for precise targeting and modulation of brain activity without the need for surgery, offering a novel way to manage epilepsy. ^{4 8 9 10 11}

What is the purpose of this trial?

This study investigates the potential for temporally-interfering electric field stimulation (TIEFS) to treat epilepsy. In this case series within and between subjects design, the impact of TIEFS on epilepsy biomarkers was studied in patients with medial temporal lobe epilepsy. Secondary analyses examine the underlying physiological effects of TIEF on local brain activity and brain networks.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

In vivo modulation of hippocampal epileptiform activity with radial electric fields. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Intracranial stimulation therapy for epilepsy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Electric stimulation on human cortex suppresses fast cortical activity and epileptic spikes. [2007]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Orientation of Temporal Interference for Non-invasive Deep Brain Stimulation in Epilepsy. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

In vivo Measurements of Electric Fields During Cranial Electrical Stimulation in the Human Brain. [2022]

6. England 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. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Electrical cortical stimulation for refractory focal epilepsy: A long-term follow-up study. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Distinct temporal patterns of electrical stimulation influence neural recruitment during PTZ infusion: an fMRI study. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Selective myelinated nerve fiber stimulation via temporal interfering electric fields. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Interindividual variability of electric fields during transcranial temporal interference stimulation (tTIS). [2022]

11. England pubmed.ncbi.nlm.nih.gov

Responses of model cortical neurons to temporal interference stimulation and related transcranial alternating current stimulation modalities. [2023]