Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Laureate Institute for Brain Research, Inc.
You may qualify if…
- ✓ 1. Persons 18-65 years old, with sex and ethnicity recruitment targets including a M:F proportion of 1:2 and White:Black:Hispanic:Native American proportion as close as possible to 8:2:2:1 to reflect the regional epidemiology of TRD (63% White American; 16% African American; 14% Hispanic of any race; 5% Native American),
- ✓ 2. DSM-5-TR diagnosis of MDD as confirmed by MINI structured interview followed by consultation with a board-certified psychiatrist,
- ✓ 3. Evidence of treatment resistance defined as continued MDD symptoms despite any of the following:
- ✓ 1. two or more adequate (6 week) trials of antidepressants with different mechanisms,
- ✓ 2. evidence-based psychotherapy,
- ✓ 3. augmentation agent (lithium, atypical antipsychotic, or T3), or
- ✓ 4. consideration of ECT or prior ECT nonresponse or intolerance,
- ✓ 4. at least moderate symptoms as indicated by MADRS≥20 upon screening
You may not qualify if…
- ✕ 1. Clinical history of at least minor neurocognitive disorder of neurodegenerative origin,
- ✕ 2. PROMIS (Cognitive Function scale) score ≤40 (i.e., mean - 1SD), collected at baseline
- ✕ 3. clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia,
- ✕ 4. uncontrolled diabetes mellitus (as evidenced by a fasting glycemia ≥ 120 mg/dL or hemoglobin A1c ≥ 6.5%) or hypertension (as evidenced by two consecutive readings ≥ 140/90 mmHg) to ensure medical stability, collected at baseline
- ✕ 5. pregnancy or lactation,
- ✕ 6. Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine, and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months,
- ✕ 7. active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS75 "Yes" answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months, collected at baseline
- ✕ 8. MRI contraindications as detected by the MRI Safety Screen, including unwillingness/unable to complete MRI scans
Where it's recruiting
Tulsa
Source: ClinicalTrials.gov · NCT07166289 · last updated 2026-03-02