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Neuromodulation

Low-intensity Ultrasound Neuromodulation for Major Depressive Disorder

N/A
Waitlist Available
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- vs 1-hour and 1-week post-sonication or sham intervention.
Awards & highlights

Study Summary

This trial aims to use a novel neuromodulation method to investigate how brain structures impact thoughts and feelings, and reduce negative thinking and distress. This is an early feasibility study to determine if this is possible.

Who is the study for?
Adults aged 18-65 with moderate to severe depression, as indicated by a PHQ-9 score of 10 or higher. Participants must have previously been part of the CoBRE study or be newly recruited if necessary. They should be in good health, not pregnant, and free from certain mental health conditions like schizophrenia or bipolar disorders.Check my eligibility
What is being tested?
The trial is testing low-intensity focused ultrasound (LIFU) on the brain to see if it can reduce repetitive negative thinking in people with depression. It's an early study to check feasibility for future research and will compare real LIFU treatment against a sham (fake) procedure.See study design
What are the potential side effects?
Since this is an early-stage trial for a non-invasive technique, specific side effects are not detailed but may include discomfort at the site of ultrasound application or temporary changes in mood or thought patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- vs 1-hour and 1-week post-sonication or sham intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- vs 1-hour and 1-week post-sonication or sham intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Sonication Change in the Intensity of Repetitive Negative Thinking
Secondary outcome measures
Suicide Safety Indicators

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Low Intensity Focused Ultrasound (LIFU)Experimental Treatment1 Intervention
An 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). Acoustic simulations will be performed with the k-Wave Matlab Toolbox to individually confirm the estimated total energy delivered during sonication and verify tissue temperature increases are <1°C, decreasing actual Power/Channel values if necessary. We estimate a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore we will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 derated ISPPA).
Group II: Sham LIFUPlacebo Group1 Intervention
Identical parameters of sonication and positioning procedures as those in the Active LIFU arm will be employed, but a Sorbothane(R) film will be interposed between the transducer and the subject's scalp.

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,315 Total Patients Enrolled
17 Trials studying Depression
2,627 Patients Enrolled for Depression

Media Library

Low-intensity focused ultrasound (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05697172 — N/A
Depression Research Study Groups: Active Low Intensity Focused Ultrasound (LIFU), Sham LIFU
Depression Clinical Trial 2023: Low-intensity focused ultrasound Highlights & Side Effects. Trial Name: NCT05697172 — N/A
Low-intensity focused ultrasound (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05697172 — N/A

Frequently Asked Questions

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

Does this clinical trial accept participants aged 75 or over?

"To be qualified for this clinical trial, individuals must be in the 18 to 65 year old age range."

Answered by AI

Is this trial currently accessible to eligible individuals?

"Clinicaltrials.gov features this medical trial, which had its initial posting on December 15th 2022 and was most recently modified on January 16th 2023. It is actively seeking qualified participants."

Answered by AI

What is the cap on patient participation in this clinical experiment?

"Affirmative. The clinical trial, which first published on December 15th 2022 is still recruiting participants according to the data hosted by clinicaltrials.gov and was most recently updated on January 16th 2023. There are 30 openings for this study at a single medical centre."

Answered by AI

Is my eligibility to join this research project contingent on any conditions?

"This medical trial is seeking 30 individuals suffering from depression, aged 18 to 65. To qualify for enrollment in the study, participants must have already taken part in CoBRE (WIRB Protocol #20182352) and been selected as one of 20 patients with major depression or 10 healthy persons without any psychiatric diagnosis; alternatively, 6 newly recruited subjects can be incorporated into this research project if not enough suitable candidates are found. Additionally, recruits need to score at least 10 on a PHQ-9 test at registration and provide contact information of two people who agree to communication with researchers when necessary. Furthermore, they should state their willingness to comply with"

Answered by AI

Who else is applying?

What site did they apply to?
Laureate Institute for Brain Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

How long will the trial last?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Low Intensity Ultrasound Neuromodulation of Repetitive Negative Thinking In Depression
2022. "Low Intensity Ultrasound Neuromodulation of Repetitive Negative Thinking In Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05697172.
~13 spots leftby Apr 2025
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