RecruitingNot applicable

Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression

Parsing Mechanistic Relationships Between Circuits and Negative Valence System Behaviors in Treatment-Resistant Depression With Ultrasound Neuromodulation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The investigators propose to address this problem by using low-intensity focused ultrasound (LIFU), which can noninvasively and reversibly modulate deep brain circuits, to determine the mechanistic relationship between cortico-subcortical circuits and distinct Negative Valence System behaviors including reward processes and rumination."
  • "The investigators will measure resting-state functional magnetic resonance imaging (fMRI) changes, and changes in two behavioral models underlying Negative Valence manifestations (monetary incentive delay and induced rumination tasks)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 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 5. stable treatments including psychotherapy and medication for at least six weeks prior to participation. 6. Fluent English speaker, capable of written consent 7. Consent that random observations of pathology are possible (e.g., brain abnormality seen during imaging) Exclusion Criteria: 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 9. medical history indicative of moderate to severe traumatic brain injury as evidenced by history of \> 5 minutes of loss of consciousness, or of skull fractures, which in theory could distort LIFU tissue propagation, and 10. a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia or bulimia nervosa), learning disability, or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g., narcissistic personality disorder, borderline personality disorder). 11. Has a history of moderate or severe substance or alcohol use disorder according to DSM-5-TR 12. Use of benzodiazepines or anticonvulsants in the 7 days prior ot screening 13. Medical, psychiatric, or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study. 14. No reliable method of communication (i.e., no access to internet or phone connection) 15. Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research 16. Unwilligness or inability to complete any of the major aspects of the study protocol 17. Non-correctable vision or hearing problems

Study sites (1)

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