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Epilepsy, Temporal LobeNCT05947656

Evaluation of the NaviFUS System in Drug Resistant Epilepsy

A study testing NaviFUS System in people with Epilepsy, Temporal Lobe and Drug Resistant Epilepsy, run by Genovate-NaviFUS (Australia) Pty Ltd. at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using NaviFUS System. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NaviFUS System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteAustralia
Study dates
2 Oct 2023to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of drug resistant temporal lobe epilepsy (TLE)
  • Patients must experience at least four (4) observable seizures over the 60-day baseline, each on a separate day.
  • Patients have focal-onset seizures with or without secondary generalization.
  • Patients have had at least 24 hours video-electroencephalography (EEG) monitoring and comprehensive epilepsy evaluation confirming TLE.
  • Seizure medication treatment is anticipated to remain stable during the trial, except for rescue medicines or occasional extra doses of ongoing medicines, as required.
  • Patients should be capable of and willing to completing assessments and neuropsychological testing in English either alone or with the help of the study partner (where appropriate), per local guidelines. A study partner is a carer or family member of the patient.
  • Patients and study partner (if applicable) who in the Investigator's opinion are reliable and able to use the seizure diary to record seizure throughout the study and are willing to comply with study procedures and visits.

Who cannot join

  • Patients who have primary generalized epilepsy or non-epileptic seizures in the last two (2) years.
  • More than two (2) seizure onset zones (foci) (except bitemporal foci) or unknown likely site of seizure onset, as determined by usual clinical, electroencephalography (EEG) and imaging practice.
  • Patients who have experienced tonic-clonic status epilepticus in the three (3) months leading up to enrollment in the study.
  • Presence of devices including but not limited to cardiac pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, responsive neurostimulator (RNS) or deep brain stimulation (DBS). Vagus nerve stimulators (VNS) do not represent an exclusion criterion, but settings should be stable throughout the trial.
  • Patients with clips or other metallic implanted objects in the FUS exposure path, except shunts.
  • Patients with more than thirty percent (30%) of the skull area traversed by the sonication pathway covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp at Screening.
Show all 17Show fewer
  • Patients who have a medical or surgical history of severe systemic disease(s), such as (but not limited to) coronary artery disease, myocardial infarct, progressive heart failure, uncontrolled hypertension or abnormal ECG, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), chronic obstructive pulmonary disease (COPD), adult respiratory distress syndrome, hepatic and renal insufficiency (ALT or AST 3 times above normal range; serum creatinine > 1.3 mg/dL), diabetic patients with poor control of blood sugar (HbA1c > 8.5 %) at Screening.
  • History of intracranial hemorrhage.
  • History of multiple strokes, or a stroke within the six (6) months prior to Screening.
  • Patients with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment at any time.
  • Presence of central nervous system (CNS) disease(s) other than epilepsy including but not limited to infections of the CNS (e.g., syphilis, Lyme disease, borreliosis, viral or bacterial meningitis/encephalitis, human immunodeficiency virus [HIV] encephalopathy), cerebral vascular disease, Parkinson's disease, traumatic brain injury, alcoholic encephalopathy within three (3) years prior to Screening.
  • Patients with concurrent major psychiatric disorder, such as schizophrenia or bipolar disorder, severe depression, active suicidal ideation, active psychosis (excluding time-limited postictal psychosis) or psychiatric hospitalization within one (1) year before Screening.
  • Prior diagnosis of cancer within the past two (2) years and evidence of continued malignancy within the past two (2) years (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).
  • Patients who are not able or willing to tolerate the required prolonged stationary semi-supine position during treatment.
  • Inability to tolerate MRI procedures or contraindication to MRI (e.g. claustrophobia, too large for MRI scanner), including, but not limited to, presence of pacemakers (with the exception of MRI-safe pacemakers), aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or other areas of the body that would contraindicate an MRI scan.
  • Patients who had major surgery six (6) weeks before study enrollment or who are not fully recovered from a surgical procedure or with planned surgery during study period or within fourteen (14) days thereafter.
  • Patients who have received radiofrequency thermocoagulation (RFTC) within two (2) months of Screening.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Reannan Duong, Ms. contact

+61 3 9076 9991

re.duong@alfred.org.au

Jack Germaine, Mr. contact

+61 3 9076 2029

j.germaine@alfred.org.au

Australia1 site, 1 recruiting

  • The Alfred

    Melbourne, Victoria, 3004

    Reannan Duong, Ms., +61 3 9076 9991, re.duong@alfred.org.au

    Terence O'Brien, Prof.

    Recruiting

Other trials in Australia

About this study

Official title: An Open-label, Non-randomized, Single-arm Pilot Study to Evaluate the Safety and Efficacy of Multiple Pulsed Focused Ultrasound Treatment in Patients With Drug Resistant Temporal Lobe Epilepsy

Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using NaviFUS System. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi.

The study consists of a 60-day screening period for baseline observation prior to treatment, a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System, and a safety follow-up period of 81 days.

Read the detailed description

Up to 30% of patients with epilepsy are resistant to current anti-seizure medications, i.e. drug-resistant epilepsy (DRE). Resective surgery of the epileptogenic regions is the most effective option to treat patients with DRE. Unfortunately, up to 60% of DRE patients are not suitable for resective surgery.

Neuromodulation approaches are increasingly being utilized in patients with DRE. The current approved techniques use invasive neuromodulation, which require complex neurosurgery and could cause side effects, such as infection, bleeding, and non-target brain tissue damage.

Focused ultrasound is a novel, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with epilepsy. NaviFUS System (a neuro-navigation guided focused ultrasound system) is one of the FUS technologies that uses low-intensity focused ultrasound (LIFU) phased array system to deliver transcranial burst-mode ultrasound energy to induce neuromodulation effect and block signals in a specific area of the brain that cause symptoms of epilepsy such as seizures. The pilot clinical study has demonstrated that NaviFUS System safely delivered LIFU to the seizure onset zone and modulated the neuronal activity.

Being tested
NaviFUS System
Keywords
Focused Ultrasound, Drug Resistant Temporal Lobe Epilepsy, Temporal Lobe Epilepsy
Medical subject headings
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaviFUS SystemDevice

    NaviFUS System (Neuronavigation-Guided Focused Ultrasound System) is a new non-invasive device, which uses the neuronavigation principle to guide focused ultrasound (FUS) energy precisely delivering through the skull to selected brain tissues without surgery in real-time. In this clinical study, the NaviFUS System is intended to deliver low intensity FUS to generate neuromodulation effects on a predetermined treatment region (one or both of the hippocampi which are associated with seizure), for the treatment for drug-resistant temporal lobe epilepsy (TLE).

Study groups in NCT05947656
Study groupRoleWhat they receive
Cohort 1ExperimentalEligible patients in Cohort 1 will receive two (2) FUS treatments per week for two (2) weeks on Day 1, 4, 8 and 11, followed by three (3) safety follow-up visits on Day 36, 64 and 92.
Receives: Device: NaviFUS System
Cohort 2ExperimentalEligible patients in Cohort 2 will receive two (2) FUS treatments per week for three (3) weeks on Day 1, 4, 8, 11, 15 and 18, followed by three (3) safety follow-up visits on Day 43, 71 and 99.
Receives: Device: NaviFUS System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, nature and severity of adverse events (AEs), serious adverse events (SAEs) and AE of special interest (seizures, headaches, mental state changes, language and memory changes, lethargy/fatigue, and nausea)

    This outcome will be assessed through the review of medical records and participant self-reporting in seizure diary.

    Measured: Up to 3 months after the last treatment session

  2. Incidence of treatment discontinuation due to AEs and SAEs

    Measured: Up to 3 months after the last treatment session

  3. Incidence of clinically significant abnormal findings from physical and neurologic examinations

    Measured: Up to 3 months after the last treatment session

  4. Incidence of clinically significant abnormal vital sign measurements, and abnormal vital signs reported as AEs and SAEs

    Measured: Up to 3 months after the last treatment session

  5. Incidence of 12-lead electrocardiogram (ECG) with clinically significant abnormal findings

    Measured: Up to 3 months after the last treatment

  6. Incidence of Magnetic Resonance Imaging (MRI) with clinically significant abnormal findings

    This outcome will be measured at Baseline Visit and 3 months after the last treatment session.

    Measured: Up to 3 months after the last treatment session

  7. Clinically significant changes in cognitive functions from baseline assessed by Boston Naming Test-Second Edition (BNT-2)

    BNT-2 is a 60-item/picture test to assess the ability to name common objects, with scores ranging from 0 to 60. Higher scores indicate better naming ability.

    Measured: Up to 3 months after the last treatment session

  8. Clinically significant changes in cognitive functions from baseline assessed by Auditory Naming Test (ANT)

    ANT is a 50-item test requiring participants to name a specific item to a description, with scores ranging from 0 to 50. Higher scores indicate better naming ability.

    Measured: Baseline Visit and 3 months after the last treatment session

  9. Clinically significant changes in cognitive functions from baseline assessed by Sentence Repetition Test (SRT)

    SRT tests immediate memory for sentences of increasing length (1-26 syllables), with scores ranging from 0 to 22. Higher scores indicate better performance.

    Measured: Baseline Visit and 3 months after the last treatment session

  10. Clinically significant changes in cognitive functions from baseline assessed by Controlled Oral Word Association Test (COWAT)

    COWAT is an oral fluency test in which the participant is required to make verbal associations to different letters of the alphabet by saying as many words as they can think of beginning with a given letter. Greater number of words produced indicates better performance on the test.

    Measured: Baseline Visit and 3 months after the last treatment session

  11. Clinically significant changes in cognitive functions from baseline assessed by Wechsler Memory Scale-4 (WMS-4)

    WMS-IV measures the ability to learn and remember information presented verbally and visually, with scores ranging from 60 to 140 (mean = 100; standard deviation = 15). Higher scores indicate better performance.

    Measured: Baseline Visit and 3 months after the last treatment session

  12. Clinically significant changes in cognitive functions from baseline assessed by Rey Auditory Verbal Learning Test (RAVLT)

    RAVLT is a test using a 15-word list to assess non-verbal learning and memory, with scores ranging from 0 to 15. Higher scores indicate better performance.

    Measured: Baseline Visit and 3 months after the last treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start2 Oct 2023
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The study consists of two (2) cohorts. Nine (9) eligible patients will be enrolled to each cohort. The only difference between the two cohorts is the overall number of weeks of treatment (2 weeks for Cohort 1 vs. 3 weeks for Cohort 2). The study investigator will advise on which cohort the patients are enrolling into as it will depend on when the patients enter the study. The safety monitoring committee (SMC) will review all safety data for Cohort 1 and confirm that it is safe to proceed with the study before the study treatment for Cohort 2 can start.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947656
Sponsor's protocol ID
GNIA22-001
Status last verified
Sep 2026
First submitted
20 Jun 2023
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NaviFUS System in people with Epilepsy, Temporal Lobe and Drug Resistant Epilepsy, run by Genovate-NaviFUS (Australia) Pty Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reannan Duong, Ms. (+61 3 9076 9991, re.duong@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, nature and severity of adverse events (AEs), serious adverse events (SAEs) and AE of special interest (seizures, headaches, mental state changes, language and memory changes, lethargy/fatigue, and nausea) (time frame: Up to 3 months after the last treatment session). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05947656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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