Epilepsy, Temporal LobeNCT02151175
Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
A study testing LIFUP in people with Epilepsy, Temporal Lobe, run by BrainSonix Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy, Temporal Lobe
- What is being tested?
- LIFUP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity.
- Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
- Subjects with epilepsy who would clearly benefit from surgical intervention.
- Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy.
Who cannot join
- Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing.
- Subjects with dementia, delirium and psychotic symptoms. - Subjects with ferromagnetic materials in the head.
- Subjects with severe cardiac disease, increased intracranial pressure, or a TENS unit.
- Subjects who exhibit primary generalized seizures or pseudoseizures.
- Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease.
- Subjects who have experienced status epilepticus during the 3-week baseline period prior to the operation.
- Subjects (females) who are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LIFUP for Treatment of Temporal Lobe Epilepsy
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.
- Conditions
- Epilepsy, Temporal Lobe
- Being tested
- LIFUP
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFUPDevice
| Study group | Role | What they receive |
|---|---|---|
| LIFUP | Experimental | Not described Receives: Device: LIFUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of histological changes
Measured: 7 days
Secondary outcomes (5)
Brief Symptom Inventory changes
Measured: 1 day
Beck Depression Inventory changes
Measured: 1 day
Neuropsychiatric changes
Measured: 1 day
Neurological changes
Measured: 1 day
Seizure frequency changes
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainSonix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment, University of California, Los Angeles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151175
- Sponsor's protocol ID
- BX001
- Status last verified
- Aug 2024
- First submitted
- 28 May 2014
- Last updated
- 6 Aug 2024
- Results posted
- No
Publications
Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
PubMed 34198105
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFUP for Treatment of Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT02151175
- Acronym / sponsor ID
- BX001
- Conditions
- Epilepsy, Temporal Lobe
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BrainSonix Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment, University of California, Los Angeles
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFUP | Experimental | Device: LIFUP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity.
- Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
- Subjects with epilepsy who would clearly benefit from surgical intervention.
- Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy.
Key exclusion criteria (7 listed)
- Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing.
- Subjects with dementia, delirium and psychotic symptoms. - Subjects with ferromagnetic materials in the head.
- Subjects with severe cardiac disease, increased intracranial pressure, or a TENS unit.
- Subjects who exhibit primary generalized seizures or pseudoseizures.
- Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFUP | Device | LIFUP |
Primary outcome
Absence of histological changes
Time frame: 7 days
5 secondary outcomes
Brief Symptom Inventory changes
Time frame: 1 day
Beck Depression Inventory changes
Time frame: 1 day
Neuropsychiatric changes
Time frame: 1 day
Neurological changes
Time frame: 1 day
Seizure frequency changes
Time frame: 6 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publication: PubMed 34198105Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFUP in people with Epilepsy, Temporal Lobe, run by BrainSonix Inc. at 1 site in United States.
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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2024. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of histological changes (time frame: 7 days). 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 NCT02151175, which also lists 1 linked publication.
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 6 Aug 2024.