Low Intensity Ultrasound Neuromodulation of Repetitive Negative Thinking In Depression (NCT05697172) | Clinical Trial Compass
CompletedNot Applicable
Low Intensity Ultrasound Neuromodulation of Repetitive Negative Thinking In Depression
United States30 participantsStarted 2022-12-15
Plain-language summary
The investigators propose to use low-intensity transcranial focused ultrasound (LIFU), a novel neuromodulation method, to probe the causal involvement of individually defined components of an anteromedial brain circuit in the processing of self-referential thoughts, and the production of repetitive negative thinking (RNT), a prominent transdiagnostic manifestation with adverse clinical consequences. The investigators hypothesize that real vs. sham low-intensity sonication of individually-defined anteromedial structures connecting medial orbitofrontal and anterior cingulate cortices with ventral striatum and anterior thalamus will show reduced initiation or maintenance of RNT as measured by (1) Brief State Rumination Inventory (BSRI) scores and distress associated to repetitive negative thoughts, and (2) improvement of the affective valence associated to self-referential adjectives, and that these changes will be associated with decreased connectivity between structures mentioned above. The present early feasibility study is an initial step that aims to determine its feasibility and help with the planning of a larger study addressed at actual hypothesis testing.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Prior participation in the CoBRE study (WIRB Protocol #20182352) and selected as a component of the propensity-matched sample of patients with major depression and varying intensities of RNT (in the form of Ruminative Response Scale (RRS) score; n=20), or healthy individuals with no psychiatric diagnosis (n=10), OR In the unexpected event that not enough participants can be recruited who meet criterion 1 (only 1 out of 6 studied patients would be incorporated into this study), participants will be newly recruited from newly recruited patients from the community or from the Mood and Anxiety Disorders inpatient unit at Laureate Psychiatric Hospital and Clinic.
. A Patient Health Questionnaire (PHQ-9) score ≥ 10 at enrollment.
. Provision of signed and dated informed consent form.
. Subject provides verifiable contact information (name, telephone number(s), email and mailing address) for at least 2 persons who agree to be contacted by study personnel as deemed necessary.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-Sonication Change in the Intensity of Repetitive Negative Thinking
Timeframe: Pre- vs 10-minute post-sonication or sham intervention.
Trial details
NCT IDNCT05697172
SponsorLaureate Institute for Brain Research, Inc.
. Subject is followed by a licensed physician or a licensed mental health care provider (i.e., psychologist, LCSW) throughout study participation outside of LIBR.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, aged 18 to 65 years.
. In good current general health as evidenced by medical history.
Exclusion criteria
. Current use (within the last 30 days) of drugs of abuse or moderate / severe alcohol use disorder.
. Lifetime diagnosis of schizophrenia spectrum disorder, other nonaffective psychotic disorders, or bipolar disorders.
. Presence of cardiac pacemaker or any other MRI contraindication.
. Pregnancy or lactation.
. Febrile illness within the last two weeks.
. Treatment with an investigational drug or participation in any other interventional research protocol in the last 2 weeks.
. The participant is unable to understand the goal of the study, instructions, or the risks associated with the study as judged by a clinically trained assessment team member.
. Clinical and/or imaging evidence of vascular, traumatic, or neurodegenerative disorders of the central nervous system (CNS), or other neurological disorders potentially compromising patient's participation in the study, or study results. This includes, but it is not limited to, any minor or major neurocognitive disorder including those caused by traumatic brain injury, Parkinson's disease, significant small-vessel disease, multiple sclerosis, Huntington's disease, early-onset Alzheimer's disease, chronic infections of the CNS or the meninges, previous chronic use of alcohol or CVA sequelae, or a Montreal Cognitive Assessment (MoCA) score \<25 due to any cause. The PI can decide if a potential participant needs to be excluded due to some other cause of structural or functional compromise of the CNS (e.g., epilepsy).