Non-invasive brain neurostimulation with Low-intensity Focused Ultrasound (LIFU)


Objective: to establish 1) confirmation of the safety and tolerance to perform a neurostimulation procedure based on Low-intensity Focused Ultrasound (LIFU); 2) the precision of spatial motor response localization with LIFU
Low-Intensity Focused Ultrasound (LIFU) is a new modality being explored to perform non-invasive neurostimulation. LIFU stimulates for a short period of time (less than a couple of seconds) a small region of the brain, producing a temporary and reversible change in brain activity. While this type of modality of neurostimulation is still at early stages, first studies in humans have indicated this procedure is safe and well-tolerated, similar as performing regular ultrasound imaging. We aim to confirm this procedure is safe from a functional point of view by comparing LIFU delivery to a sham procedure, and performing tests on hand functionality and a questionnaire about the experience of the participant. Based on previous work, our goal is to establish that LIFU neurostimulation is as safe as a sham procedure. We will also measure the capability of LIFU to produce muscle responses when the brain region responsible for hand movement is targeted with LIFU. This information will help researchers to better understand how LIFU should be used in future studies aiming to use LIFU as a potential new type of therapy.
Participants will follow a magnetic resonance imaging (MRI) session, including structural and functional measures, and ultrasound imaging of their skull. Then participants will undergo a one-hour LIFU session. In this session, participants will be randomly selected to receive either a LIFU exposure or a sham procedure. A motor evoked potential (MEP) measurement will be performed during the session. Participants will be assessed in their experience to see if any change in their hand function may have changed at the end of the procedure, and again one day, 1 week and 6 weeks after the procedure session.


Currently recruiting participants: Yes

Eligible gender: Male, Female, Transgender, Other

Eligible ages: 20 to 40

Accepts healthy participants: Yes

Inclusion criteria:

To be involved in this study, participants must:
* be healthy adults aged 18 to 40 years
* be capable of completing a Magnetic Resonance Imaging (MRI) scan.

Exclusion criteria:

Participants must not:
* have a history of seizures/epilepsy.
* be under the use of medications, such as anti-depressants, which could alter normal brain activity.
* have a history of neurological or psychiatric disorders
* have any contraindications for MR imaging such as non-MRI compatible implanted metallic devices, including cardiac pacemakers, etc.


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If you are interested in participating in this study, please contact the Principal Investigator Samuel Pichardo.

Principal investigator:

Samuel Pichardo

Clinical trial: