Dose-Dependent Effects of Low-Intensity Focused Ultrasound
ConditionHealthy Controls
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaureate Institute for Brain Research, Inc.
About this trial
Low-intensity focused ultrasound (LIFU) has emerged as a tool to modulate the activity of deep brain structures noninvasively and reversibly, with anatomical precision. Following the results of a pilot study in which the investigators observed target engagement when LIFU was applied to the anterior limb of the internal capsule, the investigators now propose to determine the dose-response relationships of LIFU when applied to deep white matter tracts of the human brain. The investigators hope a successful study will be rapidly translatable into clinical trials seeking to understand mechanistic brain circuit-symptom relationships in major psychiatric disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 65 years.
Body mass index 17-38 kg/m2.
Fluent English speaker, capable of providing written informed consent.
Overall Anxiety Severity and Impairment Scale <8 and Patient Health Questionnaire-9 <10
Disqualifiers
Inability to provide informed consent including medical, psychiatric, or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or complete the study.
No telephone or easy access to telephone
Has active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4, or 5 Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months
Has positive test result(s) for alcohol of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months
Trial design
Design model
Crossover
Treatments tested in this trial
Low-intensity focused ultrasound
Other intervention80-second stimulus with an estimated tissue ISSPA=2.26 W/cm2, administered as a single dose (1-epoch), or in multiple doses (3-epoch).
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Single Dose (1-epoch)Experimental treatment 1 intervention
Group B: Multiple Doses (3-epoch)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-Sonication Changes in Tissue Engagement
Changes in resting-state functional (fMRI) connectivity (FC) between thalamus and both subgenual (sgCC) and orbitofrontal (OFC) cortices after one vs. after three-epoch LIFU.
Time frame
Pre- vs up to 30 minutes post-sonication for 1-epoch vs 3-epoch LIFU.Secondary outcomes
1
Post-Sonication Changes in Functional Connectivity with Respect to Structural Connectivity
Establishment of a Pearson correlation between the number of thalamo-OFC and thalamo-sgCC streamlines, and resting-state fMRI FC changes between the thalamus and OFC or sgCC regions, respectively, after one- and three-LIFU epoch stimulation.
Time frame
Pre- vs up to 30 minutes post-sonication for 1-epoch vs 3-epoch LIFU.Sponsors and contacts
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Source ClinicalTrials.gov