The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety

Neurological Associates of West Los Angeles

Status: Invitation-only

Conditions: Depression; Anxiety

Treatments: Device: Focused Transcranial Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04250441

32222-2

Details and patient eligibility

About

The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with refractory depression and anxiety.

Full description

The present study is designed as an open label study of patients with refractory depression and anxiety to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with refractory depression, the target will be the subgenual cingulate (Brodmann's area 25) through a trans temporal scalp window. For patients with anxiety, the target will be the amygdala. Targeting will include reference to scalp fiducials based on the obtained MRI and Doppler waveform confirmation will be obtained because of the ability of TCD to record Doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe.

On the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the subgenual cingulate or amygdala, depending on the predetermined condition. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. Patients will undergo 8 total sessions of focused ultrasound. Patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. Safety and any adverse events will be monitored closely.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 93 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Depression:

• Diagnosis of Major Depressive Disorder
• Score greater than 13 on the Beck Depression Inventory
• Failure to remit with 3 antidepressants
• At least 18 years of age

Inclusion Criteria for Anxiety:

• Diagnosis of Generalized or Acute Anxiety Disorder
• Score greater than 15 on the Beck Anxiety Inventory
• Failure to remit with 3 anxiolytics
• At least 18 years of age

Exclusion Criteria for Depression & Anxiety:

• Cognitive decline clearly related to an acute illness
• Subjects unable to give informed consent
• Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
• Recent surgery or dental work within 3 months of the scheduled procedure.
• Pregnancy, women who may become pregnant or are breastfeeding
• Advanced terminal illness
• Any active cancer or chemotherapy
• Any other neoplastic illness or illness characterized by neovascularity
• Macular degeneration
• Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
• Advanced kidney, pulmonary, cardiac or liver failure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment

Experimental group

Description:

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Treatment:

Device: Focused Transcranial Ultrasound