RECRUITING

Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

Conditions

Impulsive Behavior transcranial focused ultrasound Magnetic Resonance Imaging Reward

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity in healthy adults.

Official Title

Modulating Ventral Striatal Activity and Connectivity With Transcranial Focused Ultrasound as a Putative Novel Intervention for Cocaine Use Disorder

Quick Facts

Study Start:2024-10-10

Study Completion:2026-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06477029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jill Morris-Tillman

CONTACT

4123838206

fmristudies@upmc.edu

Principal Investigator

Mary P Phillips, MD MD (Cantab)

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Mary Phillips, MD MD (Cantab)

Mary P Phillips, MD MD (Cantab), PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10

Study Completion Date2026-03-15

Study Record Updates

Study Start Date2024-10-10

Study Completion Date2026-03-15

Terms related to this study

Keywords Provided by Researchers

transcranial focused ultrasound
Magnetic Resonance Imaging
Reward

Additional Relevant MeSH Terms

Impulsive Behavior