Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT07099092
Eligibility Criteria:
* INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet the following criteria:
1. Willingness to comply with all study procedures and availability for the duration of the study.
2. Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals.
3. In good general health based on the assessment of the Medical Advisory Investigator (MAI).
4. Agreement to adhere to Lifestyle Considerations throughout study duration. Consent signature will be documentation of meeting this criterion.
5. Right-handed.
EXCLUSION CRITERIA
Individuals who meet any of the following criteria will be excluded from participation:
1. Any neurological disorder that would increase seizure risk from TUS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.
2. Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).
3. Current use (any use in the past week, daily use for more than one week within past 3 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), or anti or pro-convulsive action. This will be determined at the discretion of the MAI.
4. Unable to undergo MRI, or TUS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons.
5. History of noise-induced hearing loss or tinnitus.
6. Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessivecompulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI.
7. Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.
8. Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months.
9. Participation in any neuromodulation (e.g., TMS, TUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.
10. History of anaphylaxis, e.g., due to severe asthma, and/or food and non-food allergies (e.g., latex, detergents, soap, etc.).
11. History of significant chronic obstructive pulmonary disease (COPD) as increased levels of carbon dioxide may increase the susceptibility to cavitation and related tissue damage.
12. Uncorrected impairments in visual acuity severe enough to affect task participation.
13. Non-English speaking. Justification: Data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TUS and MRI procedures. The inability to effectively communicate TUS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
14. Serious skin disease or serious skin allergy on the hands or head. Justification: Gel will be applied to the skin on both head and hands, for transducer coupling and electrode placement, respectively. Allergic or adverse reactions to such treatment need to be ruled out.
15. Hyposmia, i.e., decreased sense of smell, or anosmia, i.e., loss of smell (Sniffin' Sticks Olfactory Identification Score \< 10). Justification: The ability to smell is paramount to task performance.
16. Pregnancy. Justification: It is unknown whether MRI and pose risks to fetuses.
17. Any other condition that in the judgment of the investigators is incompatible with participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07099092
Study Brief:
Protocol Section:
NCT07099092