Focused Ultrasound for Temporal Lobe Epilepsy

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BrainSonix Inc.

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

We intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional MRI, and will not cause tissue damage.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves patients with epilepsy who have not responded to at least three antiepileptic drugs, it seems likely that you may continue your current medications.

What data supports the effectiveness of the treatment Low-intensity Focused Ultrasound Pulsation (LIFUP) for temporal lobe epilepsy?

Research shows that low-intensity focused ultrasound can reduce seizure activity in animal models of epilepsy, with effects lasting up to 7 weeks. Additionally, studies indicate that this treatment can safely target brain areas without causing damage, making it a promising non-invasive option for epilepsy. ^{1 2 3 4 5}

Is focused ultrasound safe for treating epilepsy?

Research shows that low-intensity focused ultrasound (LIFUS) has been used safely in both animals and humans to target brain areas without causing damage. In a human study, a course of pulsed low-intensity focused ultrasound (PLIFUS) was delivered with no adverse events, suggesting it is generally safe. ^{1 2 3 4 6}

How does the treatment Low-intensity Focused Ultrasound Pulsation (LIFUP) differ from other treatments for temporal lobe epilepsy?

Low-intensity Focused Ultrasound Pulsation (LIFUP) is unique because it is a noninvasive treatment that uses focused sound waves to target specific brain areas without surgery or radiation. Unlike traditional treatments, LIFUP can modulate brain activity precisely and safely, offering a promising alternative for patients with drug-resistant epilepsy who are not candidates for surgery. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for people with severe epilepsy that hasn't improved after trying at least three antiepileptic drugs. They should be candidates for a specific type of brain surgery and have evidence of dysfunction in one area of the hippocampus. People can't join if they can't consent, cooperate, or have metal in their head, serious heart issues, certain neurological conditions, or are pregnant.

Inclusion Criteria

My seizures haven't improved despite trying three different epilepsy medications.

I have epilepsy not controlled by medication and have been recommended a specific brain surgery.

My tests show I have a problem with one side of my brain causing seizures.

Exclusion Criteria

Subjects with dementia, delirium and psychotic symptoms

I am able to understand and agree to the study's requirements.

I am currently pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focused ultrasound to stimulate or suppress brain activity

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low-intensity Focused Ultrasound Pulsation (LIFUP)

Trial Overview The study tests Low-intensity Focused Ultrasound Pulsation (LIFUP) to see if it can stimulate or suppress brain activity without causing damage. This non-invasive technique's effects will be monitored using functional MRI in patients who could benefit from surgical intervention.

Participant Groups

Group I: LIFUP Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

BrainSonix Inc.

Lead Sponsor

Trials

1

Recruited

10+

Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment

Collaborator

Trials

1

Recruited

10+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Findings from Research

The study successfully developed a laboratory device to deliver pulsed low-intensity focused ultrasound (PLIFUS) to the hippocampus in a patient with drug-resistant temporal lobe epilepsy, marking a first-in-human application.

The treatment was administered safely with no adverse events reported, suggesting that PLIFUS could be a promising therapeutic option for neuromodulation in neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Ultrasound Platform for Investigating Therapeutic Neuromodulation Across the Human Hippocampus. Brinker, ST., Preiswerk, F., White, PJ., et al.[2021]

In a study involving 44 male Sprague-Dawley rats, focused ultrasound (FUS) significantly reduced EEG epileptiform spikes by about 25% and bursts by about 33%, demonstrating its potential to modulate brain activity in a model of temporal lobe epilepsy.

The most effective FUS regimen used a higher intensity (0.75-MI, ISPTA 2.8 W/cm2) and longer duration (10 minutes), which not only suppressed epileptiform activity but also provided protective effects on hippocampal tissue lasting up to 14 weeks, suggesting a promising avenue for epilepsy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model. Chu, PC., Yu, HY., Lee, CC., et al.[2022]

Low intensity focused ultrasound (LIFUS) is a promising noninvasive treatment for drug-resistant epilepsy (DRE), showing potential to suppress seizures without damaging brain tissue, as demonstrated in preclinical studies and initial trials in humans.

LIFUS can precisely target specific brain regions, making it a novel alternative to traditional electrostimulatory devices, which are often palliative and not suitable for all patients, thus expanding treatment options for those with DRE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Intensity Focused Ultrasound for Epilepsy- A New Approach to Neuromodulation. Bubrick, EJ., McDannold, NJ., White, PJ.[2022]

This case report presents the first use of transcranial magnetic resonance-guided focused ultrasound (MRgFUS) for treating mesial temporal lobe epilepsy (MTLE), showing promising results as the patient remained almost seizure-free for up to 12 months after the procedure.

Despite challenges in achieving high ablation temperatures due to technical limitations, the findings suggest that MRgFUS could be a safe and feasible treatment option for MTLE, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound for mesial temporal lobe epilepsy: a case report. Abe, K., Yamaguchi, T., Hori, H., et al.[2020]

Low-intensity, pulsed focused ultrasound (FUS) significantly reduced the occurrence of epileptic EEG bursts in a rat model of epilepsy, indicating its potential efficacy in suppressing seizure activity.

The FUS treatment was non-invasive and did not cause any damage to brain tissue, suggesting it could be a safe alternative for treating epilepsy without the risks associated with invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused ultrasound-mediated suppression of chemically-induced acute epileptic EEG activity. Min, BK., Bystritsky, A., Jung, KI., et al.[2022]

Low-intensity focused ultrasound (LIFU) effectively altered the functional brain network in epileptic rats, leading to a significant reduction in network connection strength across multiple brain regions after treatment.

The study demonstrated that LIFU can modify key brain network indicators, suggesting its potential as a noninvasive treatment for epilepsy by disrupting abnormal neuronal synchronization associated with seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity Focused Ultrasound-Mediated Attenuation of Acute Seizure Activity Based on EEG Brain Functional Connectivity. Zhang, M., Li, B., Lv, X., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Focused Ultrasound Platform for Investigating Therapeutic Neuromodulation Across the Human Hippocampus. [2021]

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

Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model. [2022]

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

Low Intensity Focused Ultrasound for Epilepsy- A New Approach to Neuromodulation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound for mesial temporal lobe epilepsy: a case report. [2020]

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

Transcranial magnetic resonance-guided focused ultrasound for temporal lobe epilepsy: a laboratory feasibility study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Focused ultrasound-mediated suppression of chemically-induced acute epileptic EEG activity. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Low-Intensity Focused Ultrasound-Mediated Attenuation of Acute Seizure Activity Based on EEG Brain Functional Connectivity. [2021]