Health TrialsbyHealthPanel

SONATA LIFU for OCD

ConditionObsessive Compulsive Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22-80
SponsorUniversity of Pennsylvania

About this trial

The study tests ATTN201, an investigational non-invasive headband that delivers low-intensity focused ultrasound (LIFU) to the subthalamic nucleus (STN) as a treatment for obsessive-compulsive disorder (OCD). It's a randomized, double-blind, 1:1 (active: sham) study with 40 total participants spanning 12-16 weeks and 14 in-person and remote visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a principal diagnosis of OCD according to the DSM-5 with duration of > 1 year

Have a Y-BOCS of > 16

Participants currently on OCD medication must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating psychiatrist through the duration of the study.

Be between 22 to 80 years of age (inclusive) on the day of signing informed consent.

Disqualifiers

Has a current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorder, borderline personality disorder, Tourette's disorder

Has acute suicidality or suicide attempt or self-injurious behavior in the last 6 months

Has a history of deep brain stimulation or ablative surgery

Has a history of substance abuse including alcohol use disorder in the past 6 months (except for caffeine and nicotine)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low Intensity Focused Ultrasound

    Device

    ATTN201 is an investigational, non-invasive, wearable headband containing two ultrasound transducers positioned over the temporal region of the skull. Guided by a pre-treatment MRI, the device delivers focused low-intensity ultrasound (LIFU) to the subthalamic nucleus (STN).

  • Sham (No Treatment)

    Device

    Participants are fitted with the same ATTN201 headband used in the active arm, and the device is operated using the same procedures and audible output as active stimulation. However, the ultrasound is unfocused and does not deliver a therapeutic effect to the brain. This sham condition is designed to be indistinguishable from active stimulation to preserve blinding of participants and study staff.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active StimulationExperimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in OCD symptom severity

Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Time frame
up to 3 months
2

Incidence and severity of adverse events

Device-related and procedure-related side effects

Time frame
up to 3 months

Secondary outcomes

1

Change in Anxiety Symptoms

Beck Anxiety Inventory

Time frame
up to 3 months
2

Change in depressive symptoms

Beck Depression Inventory - II (BDI-II)

Time frame
up to 3 months
3

Change in global impression

Clinical global impression severity and clinical global impression improvement

Time frame
up to 3 months
4

Change in functional disability

Sheehan Disability Scale

Time frame
up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Attune Neurosciences Inc

Collaborator

Source ClinicalTrials.gov
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