Health TrialsbyHealthPanel

Personalized Ultrasonic Brain Stimulation for Depression (R61)

ConditionsMajor Depressive EpisodeDepression - Major Depressive DisorderTreatment-Resistant Major Depressive Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrian Mickey

About this trial

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will be delivered using a range of stimulation parameters during psychological and physiological monitoring. Individualized optimal targets will be selected using structural MRI and diffusion tractography. Brain target engagement will be evaluated using functional MRI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65, any gender.

Primary diagnosis of DMS-5 major depressive disorder (MINI).

Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months (MINI).

Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10.

Disqualifiers

History of serious brain injury or other neurologic disorder.

Poorly managed general medical condition.

Pregnant or breast feeding.

Implanted device in the head or neck.

Trial design

Design model

Crossover

Treatments tested in this trial

  • LTFUS to SCC

    Device

    Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex

  • LTFUS to ALIC

    Device

    Low-intensity transcranial focused ultrasound delivered to anterior limb of internal capsule

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group 1: SCC-ALICExperimental treatment 2 interventions
Group B: Group 2: ALIC-SCCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Modulation of SCC activity during SCC stimulation

Functional MRI is used to quantify modulation of SCC activity during SCC stimulation

Time frame
Days 14, 21, 28
2

Modulation of SCC activity during ALIC stimulation

Functional MRI is used to quantify modulation of SCC activity during ALIC stimulation

Time frame
Days 14, 21
3

Study dropout

Dropout or withdrawal due to stimulation-related adverse effects

Time frame
From enrollment to the end of participation at 7 weeks

Secondary outcomes

1

PANAS-X

Positive and Negative Affect Schedule, Expanded Form

Time frame
Immediately before and after each LTFUS on Days 14, 21, 28
2

MADRS

Montgomery-Asberg Depression Rating Scale

Time frame
Days 14, 21, 28, 35, 49
3

HDRS-6

6-item Hamilton Depression Rating Scale

Time frame
Days 0, 14, 15, 21, 22, 28, 29, 35, 49
4

IDS-SR

Inventory of Depressive Symptomatology, Self-Rated

Time frame
Days 0, 14, 21, 28, 35, 49

Other outcomes

Sponsors and contacts

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

Brian Mickey

Lead sponsor

University of Utah

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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