Actively Recruiting
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
Led by Laureate Institute for Brain Research, Inc. · Updated on 2026-03-02
140
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. In the present study we plan to use low-intensity focused ultrasound in 120 persons with treatment-resistant MDD to modulate deep white matter tracts connecting the thalamus and different regions of the prefrontal cortex reversibly and non-invasively, with the aim of assigning a causal, mechanistic role to large scale brain circuits in the production of those critical behavioral abnormalities. A successful study will help to attain the precise definition of neuromodulation targets for this clinical population in utter need of help.
CONDITIONS
Official Title
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of Major Depressive Disorder confirmed by structured interview and psychiatrist
- Evidence of treatment resistance with at least two adequate antidepressant trials, evidence-based psychotherapy, augmentation agents, or prior ECT nonresponse or intolerance
- Moderate or higher symptom severity indicated by MADRS score of 20 or above
- Stable treatments including psychotherapy and medication for at least six weeks before participation
- Fluent English speaker able to provide written consent
- Consent to random observation of brain pathology during imaging
You will not qualify if you...
- History of minor neurocognitive disorder of neurodegenerative origin
- PROMIS Cognitive Function score of 40 or below at baseline
- History of structural brain pathology such as Parkinson's disease, multiple sclerosis, or brain cancer
- Uncontrolled diabetes or hypertension at baseline
- Pregnancy or lactation
- Positive test for alcohol or drug abuse or substance use disorder exceeding mild severity in past 6 months
- Active suicidal ideation or suicide attempt within last 3 months
- MRI contraindications or inability/unwillingness to complete MRI scans
- History of moderate to severe traumatic brain injury or skull fractures
- Current diagnosis of psychotic, eating, learning disability, or interfering personality disorder
- History of moderate or severe substance or alcohol use disorder
- Use of benzodiazepines or anticonvulsants within 7 days prior to screening
- Medical, psychiatric, or other conditions limiting consent, adherence, or study completion
- No reliable communication method (internet or phone)
- Use of medications outside accepted range per clinical judgment
- Unwillingness or inability to complete major study procedures
- Non-correctable vision or hearing impairments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
Research Team
S
Salvador M Guinjoan, MD, PhD
CONTACT
D
Danielle E Clark, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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