Low Intensity Focused Ultrasound for Emotion Regulation

Cognitive Impairment Clinical Trial

— LIFUPEMOT  

Official title:

Low Intensity Focused Ultrasound as a Non-Invasive Neural Prosthetic for the Improvement of Emotion Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782194
• Other study ID #: IRB#18-000978
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: August 24, 2022

Study information

• Verified date: September 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Amygdala is highly involved in emotional response, emotional reactivity and anxiety. Amygdala functions are therefore involved in a wide range of psychiatric disorders including generalized and social anxiety, specific phobia, obsessive compulsive disorder and posttraumatic stress disorder. Therefore, potential clinical implications of amygdala stimulation are great. However, to date, such efforts have been limited by the inability of non-invasive neuromodulation techniques (e.g. transcranial magnetic stimulation - TMS) to reach the amygdala and the highly invasive (i.e. neurosurgical) nature of methods (e.g. deep brain stimulation - DBS) which can, but to our knowledge has rarely been used, target these areas. In order to overcome these current limitations, study invesitgators propose the use of low intensity focused ultrasound pulsation (LIFUP) to affect amygdala activity to improve emotion regulation.

Description:

Study investigators propose the use of personalized neuronavigation, based on each participant's structural brain MRI, to aim LIFUP at the amygdala in the pursuit of enhancement of emotionality in humans. A comprehensive approach will integrate behavioral and multimodal neuroimaging to assess the utility of LIFUP to increase activity in deep neural structures and in the regulation of anxiety. Further, this is the first study to use LIFUP in (A) amygdala in humans and (B) for pro-cognitive effects. Findings from this study will provide important insight into the utility of LIFUP modulation of subcortical regions and their associated networks and functions, which have wide ranging implications for clinical LIFUP as a therapeutic device for numerous patient populations. By characterizing the effect of LIFUP on the amygdala and associated networks, this study will provide the foundation on which LIFUP can be validated as an effective neural prosthetic and as a treatment tools for psychiatric patient populations. Participants will complete a brief T1-weighted structural brain scan. Then, they will be removed from the scanner and, using the T1 image in Neurocare Brainsight software, the LIFUP transducer will be aimed at the amygdala and gently strapped in place to their head. Participants will then return to the scanner where a second T1 image will verify the position of the LIFUP transducer and allow for estimation of the spatial location of the sonification beam focus (approximately .5cm long x 7mm diameter). Blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) will be collected during two conditions: short train sonification LIFUP and sham LIFUP: total time = 20min. Short train LIFUP (previously used in primary sensory cortices47 will be administered in 75 sonifications at 210 Kilohertz (KHz) frequency with pulse repetition frequency of 500 Hertz (Hz), 35mW/cm2, sonification duration 0.5s with 7s inter-stimulation interval. Sham LIFUP will involve the same procedures (e.g. participant provided the same instructions) except the sonification will not occur. Before and after completing the scan and a short break, these participants will receive short train LIFUP while they are administered a series of three computerized, amygdala-mediated emotion reactivity and regulation tasks. Given that routine clinical neuropsychological measures are designed to provide diagnostic information and are not sensitive or specific enough to precisely measure longitudinal emotional change related to an intervention, investigators will use validated experimental neurocognitive measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must be between 18-65 years of age
• Must be right handed
• English must be the dominant language

Exclusion Criteria:

• contraindications for MRI (e.g. metal implants, pregnancy)
• history of head injury sufficient to warrant medical attention
• history of alcohol abuse or dependence
• history of substance abuse or dependence
• history of major psychiatric illness requiring treatment
• history of cancer or other neoplastic syndromes
• history of major neurologic illness (e.g. epilepsy).

Related Conditions & MeSH terms

• Anxiety Disorders
• Cognitive Impairment
• Disease
• Mental Disorders
• Mood Disorders
• Problem Behavior
• Psychiatric Disorder
• PTSD
• Social Anxiety

Intervention

Device:
• Low Intensity Focused Ultrasound Pulsation
A low intensity, focused ultrasound pulsation causes mechanical changed without causing heating or cavitation.
• Sham Ultrasound
Low Intensity Focused Ultrasound Pulsation Transducer is left in place on the participant's head but is not turned on during the sham procedure.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion Reactivity	Psychophysiological reactivity, measured via Galvonic skin response, to emotionally salient images.	Day 1
Secondary	BOLD fMRI Signal in the Amygdala	BOLD data will be collected in real-time during the ultrasound sonication, which occurs in on-off blocks. Analyses will assess the statistical relationship between BOLD signal in the brain and the time series (on vs off) of the ultrasound sonication.	Day 1
Secondary	Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain	Perfusion ASL fMRI data will be collected before and after sonication. Analyses will assess the statistical relationship between ASL signal throughout the brain pre and post sonication in a within subject repeated measures design.	Day 1