Evidence map›Paper›PMID 41282732›Full record

ArticlemedRxiv : the preprint server for health sciences2025

Dose-Escalation Study of Amygdalar Transcranial Focused Ultrasound in Healthy Volunteers.

Norman M Spivak, Andrew A E D Bishay, Jonathan Haroon, Amber R Hopkins, Jody Tanabe, Sabrina Halavi, Bianca Hoang-Dang, Andrew J Swenson, Samantha F Schafer, Mark E Schafer and 3 more

Registry-linked trialAbstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07599592 (Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07599592 early_phase1recruitingnot on this mapstarted 2026, after this paper: background citation

Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor

TypeinterventionalSponsorUniversity of California, Los AngelesRan2026 to 2027Enrolled20ConditionsEssential TremorArmsLow Intensity Focused Ultrasound (LIFU)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Norman M SpivakDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.ORCID 0000-0002-2386-2987
Andrew A E D BishayDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.ORCID 0009-0005-7854-3763
Jonathan HaroonDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Amber R HopkinsDepartment of Psychology, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Jody TanabeDepartment of Radiology, CU School of Medicine Anschutz Medical Center, Aurora, CO.
Sabrina HalaviDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Bianca Hoang-DangDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Andrew J SwensonDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Samantha F SchaferSchool of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA.
Mark E SchaferSchool of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA.
Alexander BystritskyDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Susan Y BookheimerDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.
Martin M MontiDepartment of Psychiatry & Biobehavioral Sciences, UCLA, 760 Westwood Plaza, Suite C8-519, Los Angeles, CA 90095, United States.

Funding

UCLA-Caltech Medical Scientist Training ProgramT32GM008042 · NIGMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI AJIJOLA, OLUJIMI A, DAWSON, DAVID WAYNE · 1985 to 2023
$29.9M
Seeing Sound: Visualizing the Target of Transcranial Focused UltrasoundF30MH136802 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SPIVAK, NORMAN MITCHEL · 2024 to 2025
$83k
NIGMS NIH HHS T32 GM008042NIMH NIH HHS F30 MH136802
6 · The paper itself

Abstract

Background: Transcranial focused ultrasound (tFUS) is a promising noninvasive technique for modulating deep brain structures, but the optimal and safe intensity range for neuromodulation remains unclear. Current FDA intensity limits, designed for diagnostic use rather than therapy, may limit the potential effectiveness of tFUS. Objective: This study aimed to evaluate the safety and preliminary efficacy of escalating tFUS intensities targeting the right amygdala in healthy volunteers, including intensity levels exceeding current FDA diagnostic ultrasound limits. Methods: Ten healthy adults (mean age = 19.5 ± 1.4 years; 70% female) participated in a within-subject, repeated-measures design. Each received four randomized tFUS stimulation conditions (ISPTA.3 = 0.72-10.08 W/cm Results: No adverse events or MRI-detectable structural changes (e.g., edema, hemorrhage, or microstructural abnormalities) occurred under any stimulation condition. Behavioral analyses revealed no significant overall effects of intensity on affective measures. Comparisons between excitatory and inhibitory paradigms showed no significant differences. Conclusions: tFUS of the right amygdala at intensities up to 10.08 W/cm

Identifiers

PMID41282732
PMCPMC12636638

What OpenQuestion holds

Textmetadata
LicenceCC BY-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.