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Official title Dose-Dependent Effects of Low-Intensity Focused Ultrasound
ClinicalTrials.gov ID: NCT07099950
What this study is testing
- What it's testing
- Low-intensity focused ultrasound (LIFU) has emerged as a tool to modulate the activity of deep brain structures noninvasively and reversibly, with anatomical precision. Following the results of a pilot study in which the investigators observed target engagement when LIFU was applied to the anterior limb of the internal capsule, the investigators now propose to determine the dose-response relationships of LIFU when applied to deep white matter tracts of the human brain.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age 18 to 65 years.
- Body mass index 17-38 kg/m2.
- Fluent English speaker, capable of providing written informed consent.
- Overall Anxiety Severity and Impairment Scale \<8 and Patient Health Questionnaire-9 \<10
- A person of childbearing potential must have a negative urine pregnancy test at screening
You likely can't join if
- Inability to provide informed consent including medical, psychiatric, or other conditions that restrict the patient's following abilities: to...
- No telephone or easy access to telephone
- Has active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4, or 5 Suicidal Ideation-Past 1 month section...
- Has positive test result(s) for alcohol of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine and ecstasy), or substance use...
- Has a lifetime APA Diagnostic and Statistical Manual of Mental Disorders (DSM)-5th edition including major depression, generalized anxiety disorder...
- Benzodiazepines or anticonvulsants in the 7 days prior to participation.
See the full eligibility criteria
- Age 18 to 65 years.
- Body mass index 17-38 kg/m2.
- Fluent English speaker, capable of providing written informed consent.
- Overall Anxiety Severity and Impairment Scale \<8 and Patient Health Questionnaire-9 \<10
- A person of childbearing potential must have a negative urine pregnancy test at screening
- Consent that random observations of pathology are possible (e.g., brain abnormality seen during imaging).
- Inability to provide informed consent including 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...
- No telephone or easy access to telephone
- Has active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4, or 5 Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3...
- Has positive test result(s) for alcohol of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis...
- Has a lifetime APA Diagnostic and Statistical Manual of Mental Disorders (DSM)-5th edition including major depression, generalized anxiety disorder, specific phobias, panic disorder, post-traumatic stress disorder...
- Benzodiazepines or anticonvulsants in the 7 days prior to participation.
- MRI contradictions as detected by the MRI Safety Screen including claustrophobia and unwillingness and inability to complete scans (e.g., unable to lie on one's back for 60 mins.
- Clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia.
- History of unstable liver or renal insufficiency; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatological, or metabolic disturbance; or any other...
- Moderate-to-severe traumatic brain injury or any other clinical neurocognitive disorder.
- Clinical history of at least minor neurocognitive disorder of any origin.
- Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research.
- Use of any psychotropic medication.
- Unwillingness or inability to complete any major aspects of the study protocol.
- Prior neurosurgery.
- Non-correctable vision or hearing.
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.