Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

Launched by MARY PHILLIPS, MD MD (CANTAB) · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how a specific technique called transcranial focused ultrasound (tFUS) affects brain activity in healthy adults. The researchers want to understand if this non-invasive method can influence impulsive behaviors. The trial is currently looking for participants aged between 18 and 35 who do not have a history of certain mental health conditions, such as major depression or bipolar disorder, and who also have no family history of these conditions. This is important to ensure that the results are not influenced by underlying mental health issues.

If you decide to participate, you will undergo a series of tFUS sessions where ultrasound waves are directed at your brain to see how it responds. Before joining, you'll go through some screening tests to ensure you meet the eligibility criteria, which includes being free of specific neurological problems and not using certain substances. It’s a great opportunity to contribute to research that could help us better understand brain functions related to impulsivity. If you have any questions or concerns, the trial team will be there to guide you through the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • No present/lifetime history of major depressive disorder (MDD), psychosis, Bipolar Disorder; Hamilton Depression Rating Scale (HDRS)\>7; Young Mania Rating Scale (YMRS)\>10), borderline personality disorder, and present suicidal ideation
• • No family history of MDD, psychosis, Bipolar Disorder, or epilepsy
• Exclusion Criteria:
• • Present/lifetime history of MDD, psychosis, Bipolar Disorder (HDRS\>7; YMRS\>10), borderline personality disorder, and present suicidal ideation. Childhood history of, but not present, anxiety disorders and Attention-deficit/hyperactivity disorder (ADHD) will be allowed as these are common disorders in childhood
• • Family history of MDD, psychosis, Bipolar Disorder, or epilepsy
• • History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report)
• • Use of substances with seizure risk (e.g., stimulants) in the past month, as for other non-invasive neuromodulation techniques, assessed as screening and before each tFUS session
• • Mini-Mental State Examination (MMSE) score (cognitive state) \<24
• • Premorbid North American Adult Reading Test (NAART) intelligence quotient (IQ) estimate \<85;
• • Visual disturbance: \<20/40 (Snellen visual acuity)
• • Left/mixed handedness (Annett criteria)
• • History of alcohol or other substance use disorder (SUD), daily nicotine use, and/or illicit substance use over the last 3 months (SCID-5). Note: lifetime/present cannabis use (\<3 times in the past month) at non-SUD levels will be allowed, given its common usage in young adults. Urine tests on scan days will exclude current illicit substance use. Salivary alcohol tests on scan days will exclude intoxicated individuals
• • Binge drinking (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAA) criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or \>3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tFUS scan day, confirmed at screening and scan days. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 SUD and binge levels) will be allowed
• • MRI exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
• • Unable to understand English
• • Taking any psychotropic medications in the past 3 months
• • Any implanted neural device