Focused Ultrasound for Behavioral Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorAttune Neurosciences Inc
About this trial
This is a double-blind, within-participant crossover, multi-site dose-finding study evaluating the safety, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound (LIFU) stimulation using the ATTN201 device across seven candidate deep-brain targets in adults with subsyndromal-to-moderate depression, anxiety, or obsessive-compulsive disorder. Every session delivers active ATTN201 stimulation; there is no sham or placebo condition. Participants and the on-site study staff who deliver stimulation and administer the clinical scales are blinded to the brain target and to the stimulation parameters assigned for each session by a constrained Bayesian optimization algorithm.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be between 22 and 80 years of age (inclusive) on the day of signing informed consent.
Have at least one of the following at screening: PHQ-9 total score 5-16 (depression), GAD-7 total score 5-14 (anxiety), or OCI-R total score 14-27 (obsessive-compulsive disorder).
If currently taking psychiatric medication, have been on the same stable dose(s) for at least 4 weeks prior to screening and be willing to maintain the regimen throughout the treatment period.
Be able and willing to undergo a multi-sequence cranial MRI.
Disqualifiers
Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent, with or without plan) at screening.
Any suicide attempt within the past 12 months.
Any change in psychiatric medication (start, stop, or dose change) within 4 weeks prior to screening.
Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or prevent completion of study procedures. Stable comorbid conditions (e.g., treated depression, anxiety, OCD, insomnia) within the protocol-specified score windows are permitted.
Trial design
Design model
Crossover
Treatments tested in this trial
ATTN201 head-worn focused ultrasound
DeviceATTN201 head-worn focused ultrasound
Treatment groups
300 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Basolateral amygdala (BLA)Experimental treatment 1 intervention
Group B: Dorsal anterior cingulate cortex (dACC)Experimental treatment 1 intervention
Group C: Anterior limb of internal capsule (ALIC)Experimental treatment 1 intervention
Group D: Centromedian nucleus of thalamus (CMN)Experimental treatment 1 intervention
Group E: Rostral zona incerta (rZi)Experimental treatment 1 intervention
Group F: Subthalamic nucleus (STN)Experimental treatment 1 intervention
Group G: Anterior nucleus of thalamus (ANT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient-specific transdiagnostic score (TDx) at 1 week after stimulation
TDx measured 1 week after each stimulation session. The TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
Time frame
1 week after each stimulation sessionSecondary outcomes
1
Patient-specific transdiagnostic score (TDx) at 2 weeks after stimulation
TDx measured 2 weeks after each stimulation session. The TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
Time frame
2 weeks after each stimulation session2
Posterior mean transdiagnostic score (TDx) at the best stimulation parameter set for each brain target
Posterior mean TDx, from a Gaussian process model fit for each brain target, at the stimulation parameter set that maximizes it. TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
Time frame
At study completion, up to 19 months3
Change from pre-stimulation baseline in PHQ-9 total score
Change from the local pre-stimulation baseline in Patient Health Questionnaire-9 (PHQ-9) total score. The PHQ-9 is a 9-item self-report measure of depression severity over the preceding 2 weeks. Total score range is 0 to 27; higher scores indicate greater depression severity. A negative change score indicates improvement.
Time frame
Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation4
Change from pre-stimulation baseline in GAD-7 total score
Change from the local pre-stimulation baseline in Generalized Anxiety Disorder-7 (GAD-7) total score. The GAD-7 is a 7-item self-report measure of anxiety severity over the preceding 2 weeks. Total score range is 0 to 21; higher scores indicate greater anxiety severity. A negative change score indicates improvement.
Time frame
Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Attune Neurosciences Inc
Lead sponsor
University of California, San Francisco
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov
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