The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety
NCT ID: NCT04250441
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
100 participants
INTERVENTIONAL
2018-11-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.
Focused Transcranial Ultrasound
The FDA has determined that power intensity limits of 720 mW/cm squared at 2 megaHertz is safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion.
Interventions
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Focused Transcranial Ultrasound
The FDA has determined that power intensity limits of 720 mW/cm squared at 2 megaHertz is safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion.
Eligibility Criteria
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Inclusion Criteria
* Score greater than 13 on the Beck Depression Inventory
* Failure to remit with 3 antidepressants
* At least 18 years of age
* 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
* 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
18 Years
93 Years
ALL
No
Sponsors
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Neurological Associates of West Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Sheldon Jordan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurological Associates - the Interventional Group
Locations
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Neurological Associates of West LA
Santa Monica, California, United States
Countries
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References
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Other Identifiers
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32222-2
Identifier Type: -
Identifier Source: org_study_id
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