Epilepsy Trial, Recruiting NCT05947656 Sponsor: Genovate-NaviFUS (Australia) Pty Ltd. Condition: Epilepsy
Back to Epilepsy

Epilepsy Trial, Recruiting

NCT05947656
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with temporal lobe epilepsy (a type of epilepsy starting in the temporal lobe of the brain) that has not been controlled by medication.
  • You have had at least 4 seizures over a 60-day observation period, with each seizure happening on a different day.
  • Your seizures start in one focused area of the brain, and may or may not spread to affect the whole brain.
  • You have had at least 24 hours of brain activity monitoring (using video and electrode recordings of brain waves) that confirmed your diagnosis.
  • Your seizure medications are expected to stay the same throughout the trial, apart from emergency or occasional extra doses if needed.
  • You are able and willing to complete assessments and memory/thinking tests in English, either on your own or with the help of a carer or family member.
  • You and your carer or family member (if involved) are able and willing to keep a regular seizure diary and attend study visits as required.

Who may not be able to join:

  • You have a type of epilepsy where seizures affect the whole brain from the start, or you have had seizures that are not caused by epilepsy, in the last 2 years.
  • Your seizures appear to start in more than 2 different areas of the brain (except when both temporal lobes are involved), or the starting point of your seizures is unknown.
  • You have had a severe, prolonged seizure (tonic-clonic status epilepticus) in the 3 months before joining the study.
  • You have certain implanted medical devices in your body, such as a heart pacemaker, a defibrillator, a permanent medication pump, a cochlear (ear) implant, or certain brain stimulation devices. (Note: a vagus nerve stimulator may be allowed if its settings are stable — confirm with trial site.)
  • You have metal clips or other metal implants in the area of the head that would be treated, except for certain brain fluid drainage tubes (shunts).
  • More than 30% of the scalp area in the treatment path is affected by scars, skin conditions (such as eczema), or thinning of the scalp.
  • You have a serious ongoing health condition such as significant heart disease, uncontrolled high blood pressure, severe lung disease, liver or kidney problems, or poorly controlled diabetes (confirm with trial site for specific measurements).
  • You have a history of bleeding inside the brain.
  • You have had multiple strokes, or a stroke within the last 6 months.
  • You have a brain aneurysm or abnormal blood vessel in the brain that needs treatment.
  • You have another condition affecting the brain or nervous system, such as certain infections, Parkinson's disease, traumatic brain injury, or alcohol-related brain damage within the last 3 years.
  • You have a significant mental health condition such as schizophrenia, bipolar disorder, severe depression, active thoughts of suicide, or active psychosis, or you have been hospitalised for a psychiatric condition in the past year.
  • You have been diagnosed with cancer in the past 2 years, or there is still evidence of cancer (some minor skin cancers or certain early-stage cancers that have been fully treated may be exceptions — confirm with trial site).
  • You are unable or unwilling to lie still in a semi-reclined position for an extended period during the treatment.
  • You are unable to have an MRI scan for any reason, such as claustrophobia, body size, or having certain metal objects or implants in your body.
  • You have had major surgery in the 6 weeks before joining the study, have not fully recovered from a recent operation, or have surgery planned during the study period or within 2 weeks after it ends.
  • You have had a specific brain treatment called radiofrequency thermocoagulation (RFTC) within 2 months before the study screening (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Terrence O'Brien, Prof., The Alfred

Phone: +61 3 9076 2598

Australian sites

The Alfred, Melbourne, Victoria
+61 3 9076 2598

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Genovate-NaviFUS (Australia) Pty Ltd.
Registry
ClinicalTrials.gov
Start date
2 October 2023
Est. completion
1 July 2026

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

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); Incidence of treatment discontinuation due to AEs and SAEs; Incidence of clinically significant abnormal findings from physical and neurologic examinations; Incidence of clinically significant abnormal vital sign measurements, and abnormal vital signs reported as AEs and SAEs; Incidence of 12-lead electrocardiogram (ECG) with clinically significant abnormal findings; Incidence of...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov