Clinical trial NCT04250441: The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety
Official title: The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline prior to ultrasound administration (
measure: Hamilton Anxiety Rating Scale
timeFrame: Baseline prior to ultrasound administration
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: After final ultrasound (8 weeks from baseline)
measure: Beck Anxiety Inventory
timeFrame: Baseline prior to ultrasound administration
measure: Beck Anxiety Inventory
timeFrame: After final ultrasound (8 weeks from baseline)
measure: Patient Depression Questionnaire
timeFrame: After final ultrasound (8 weeks from baseline)
measure: Hamilton Depression Rating Scale
timeFrame: Baseline prior to ultrasound administration
measure: Hamilton Depression Rating Scale
timeFrame: After final ultrasound (8 weeks from baseline)
measure: Beck Depression Inventory
timeFrame: After final ultrasound (8 weeks from baseline)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
Study officials:
affiliation: Neurological Associates - the Interventional Group
name: Sheldon Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
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