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Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy

NCT03657056 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-16

No results posted yet for this study

Summary

The aim of the proposed study is to assess the feasibility of using the BrainSonix BX Pulsar 1002 low-frequency and Low-Intensity Focused Ultrasound Pulsations (LIFUP) in human subjects suffering from intractable temporal lobe epilepsy. The patients selected will already be scheduled to undergo surgery for resection of the temporal lobe, and the investigational therapy will be applied to the temporal lobe at least one day prior to its scheduled removal. The study is intended to provide preliminary evidence of safety, and establish the feasibility of LIFUP treatment as evidenced by a modulation of the Blood-oxygenation level dependent (BOLD) signal in functional MRI (fMRI), and normal findings from histological examination of the resected brain tissue.

Conditions

  • Low Intensity Ultrasound Pulsarions

Interventions

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).

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Darin Dougherty, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-03-01
Completion
2023-03-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03657056 on ClinicalTrials.gov