Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy (LIFUP)
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|ClinicalTrials.gov Identifier: NCT03657056|
Recruitment Status : Not yet recruiting
First Posted : September 3, 2018
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low Intensity Ultrasound Pulsarions||Device: BX Pulsar 1002||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Participants will be recruited from the normal population of patients being treated for temporal lobe epilepsy Massachusetts General Hospital.
Patients identified as candidates for temporal lobe surgery by the clinical team will be notified via a letter that has been signed by a physician representative of the practice of their eligibility for the study. An administrator will follow-up on the letter with a phone call. The physician of potential participants will be notified of their eligibility for the study, and be provided with a copy of the consent form. A total of 3 participants will be enrolled in the project.
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: BX Pulsar 1002
Low-Intensity Focused Ultrasound Pulsation (LIFUP) sonications will be conducted using the LIFUP experimental device BX Pulsar 1002 produced by the Brainsonix Corporation. For the purposes of safety LIFUP sonications will be initiated at the FDA limit for diagnostic ultrasound. However, the minimally effective dose in humans applications, according to (Lee et al., 2015), when derated is approximately 1125mW/cm2.
Device: BX Pulsar 1002
LIFUP will be administered to the temporal region on the side to undergo surgery, within the focus producing seizures. The ultrasound will be focused on the highest activity area within the temporal lobe. Functional MRI of the brain will be obtained throughout the LIFUP session.
After the participant is fitted with the transducer they will be placed in the MRI machine and undergo a series of scans. After placing the transducer over the anterior tip of the temporal lobe the participant will undergo fMRI BOLD scans with LIFUP excitation (from (Lee et al., 2015): Tone Burst Duration = 2ms and Pulse Repetition Frequency = 250Hz) at four levels of intensity (720mW/cm2, 1440mW/cm2, 2880mW/cm2 and 5760mW/cm2). Before increasing the intensity, the transducer will be moved approximately 5mm posterior. After the last excitation scan the LIFUP parameters will be changed to inhibitory parameters (from (Yoo et al., 2011): Tone Burst Duration = 0.5ms and Pulse Repetition Frequency = 100Hz).
Other Name: LIFUP
- FMRI - (Change in BOLD signal) [ Time Frame: 6 Months ]Change in BOLD signal during or after LIFUP sonication