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Non-invasive Brain Stimulation

Low Intensity Focused Ultrasound for Depression and Anxiety (LIFU Trial)

N/A

Recruiting

Led By Noah S Philip, MD

Research Sponsored by Ocean State Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteers must have an absence of psychiatric disorders (>6 months; lifetime for major depression and PTSD) and absence of psychiatric medications or therapy for >6 months

Patients must meet DSM-5 criteria for major depressive disorder with and without anxiety symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post lifu

Awards & highlights

LIFU Trial Summary

This trial will study whether low intensity focused ultrasound (LIFU) is safe and can be used to change brain activity in areas connected to depression and anxiety symptoms. Up to 25 patients and 25 healthy veterans will be recruited, and participants will undergo clinical and research neuroimaging, neuropsychological testing, complete questionnaires, and participate in clinical/neurological assessments. Two patient visits will include the LIFU application.

Who is the study for?

This trial is for veterans with depression and/or anxiety who have been stable on treatments for over 6 weeks. Healthy volunteers without psychiatric disorders or medications in the past 6 months can also join. Exclusions include those with brain surgery, severe head injuries, substance abuse issues, pacemakers, metal in the head, severe vision/hearing/hand impairments, pregnancy, inability to follow protocols or very severe symptoms.Check my eligibility

What is being tested?

The study tests Low Intensity Focused Ultrasound (LIFU) as a non-invasive way to target deep brain structures linked to depression and anxiety. It will assess safety and ability of LIFU to alter brain activity during tasks. Participants undergo up to 14 visits including neuroimaging and neuropsychological testing; some receive LIFU while performing tasks.See study design

What are the potential side effects?

While the main focus is on safety and tolerability of LIFU for treating psychiatric conditions, potential side effects are not detailed but may include discomfort at stimulation site or temporary changes in mood or cognition due to brain activity alteration.

LIFU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had major depression, PTSD, or any psychiatric treatment for over 6 months.

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I have been diagnosed with major depression, with or without anxiety.

LIFU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post lifu

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post lifu

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post lifu for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BOLD fMRI Signal

Magnetic Resonance Imaging

Incidence of LIFU-related adverse events as assessed by neurological examinations

+3 more

LIFU Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Target Site Low Intensity Focused UltrasoundExperimental Treatment1 Intervention

Low Intensity focused ultrasound of the target region. These are at a fundamental frequency = 650kHz, PRF = 10Hz, pulse width = 5ms, duty cycle = 5%; ISPTA.3 of 720 mW/cm2. As in prior studies, each sonication includes 10 pulsations, each lasting 30s, followed by 30s pause intervals; two 10-minute administrations provided per LIFU session.

Group II: Control Site Low Intensity Focused UltrasoundActive Control1 Intervention

Low Intensity focused ultrasound of the control region. These are at a fundamental frequency = 650kHz, PRF = 10Hz, pulse width = 5ms, duty cycle = 5%; ISPTA.3 of 720 mW/cm2. As in prior studies, each sonication includes 10 pulsations, each lasting 30s, followed by 30s pause intervals; two 10-minute administrations provided per LIFU session.

Group III: Healthy ControlActive Control1 Intervention

25 age- and sex-matched healthy controls will be recruited and complete fMRI tasks. They will not receive low intensity focused ultrasound.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ocean State Research Institute, Inc.Lead Sponsor

2 Previous Clinical Trials

254 Total Patients Enrolled

Noah S Philip, MDPrincipal InvestigatorVA Providence Healthcare System

3 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Depression

32 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to become a subject of this clinical trial?

"This research will accept 50 persons suffering from depression aged between 22 and 75. To qualify, they must demonstrate symptom severity over clinical thresholds with standard rating scales; if applicable, also maintain steady treatments for at least 6 weeks. Healthy volunteers need to have been free of psychiatric conditions (for a minimum of 6 months - lifetime in the case of major depression or PTSD) and abstain from taking psychotropic medications/ therapies for no less than half a year."

Answered by AI

Is recruitment ongoing for this research endeavor?

"Affirmative, the info on clinicaltrials.gov presents that this medical experiment is actively recruiting patients. This endeavor was initially announced on September 28th 2021 and has been updated as recently as July 7th 2022. There are 50 slots available at a single site for enrollment in this trial."

Answered by AI

How many subjects are involved in this trial?

"Affirmative. Clinicaltrials.gov displays that the trial, which was initially published on September 28th 2021, is still open for recruitment. 50 patients are needed to be registered from a single medical facility."

Answered by AI

Is the age limit of this trial restricted to those under 25 years old?

"Those wishing to enrol in this trial must between the ages of 22 and 75. There are 192 trials for those aged 18 or younger, while 962 studies cater towards older individuals over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?

Other

Pennsylvania

Rhode Island

Massachusetts

How old are they?

65+

18 - 65

What site did they apply to?

VA Providence Healthcare System

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have had depression my entire life. Many drugs that didn’t work were tried.

PatientReceived 1 prior treatment

I have had depression and anxiety since childhood for decades I've tried every major medication under the sun. I have been waiting for this technology for decades. I have been waiting for low frequency ultrasound to be used to treat depression before it was researched. The idea that I will have to wait another 20 or 30 years before people figure out how to properly use it worries me and I am willing to travel to receive the benefits of it.

PatientReceived 1 prior treatment

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