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NCT07671079
Closed-loop tES-non-invasive Stimulation
Conditions: Closed-loop Brain Stimulation
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: University of Nottingham
Location: University of Nottingham Nottingham
Summary
The goal of this study is to establish if non-invasive closed-loop neuromodulation is an effective approach to enhance cognitive function in healthy 18-40 years old volunteers. The main questions it aims to answer are:
* Can closed-loop stimulation increase stimulation effectiveness?
* Can closed-loop focused ultrasound specifically engage with excitatory or inhibitory neural populations in the target structure as measured through MRS?
* Can observed stimulation outcomes for FUS be predicted through connectome analysis and computational models of indirect changes?
Researchers will compare different closed-loop options to their open-loop counterpart to see if closed-loop approaches can increase efficacy and reduce the variability of the stimulation compared to open-loop approaches.
Participants will:
* Answer some questionnaires at the start of the study and after each intervention session.
* Undertake a MRI scanning session.
* Undertake one open-loop FUS session.
* Undertake one tES session.
* Undertake one closed-loop FUS sessions involving tES and FUS, followed by a MRI scanning
* Undertake one sham FUS session
* Attend one visit in person to assess eligibility through questionnaires and one cognitive task
Eligibility Criteria
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study
* Aged between 18 and 40
* Good general health
* Not consume alcohol 48 hours prior study visit
* Not currently taking any medications (except contraceptive pills) or if on long-term medication for a non-neurological/non-psychiatric condition (r.g. inhalers) to be considered otherwise healthy and stable with no symptoms
* Be right handedness
Exclusion Criteria:
* Inability to complete MRI/FUS/TMS/tES safety questionnaire and / or informed consent process.
* Current or previous diagnosis of a neurological, neurosurgical, psychiatric disorders.
* Other significant medical condition (specific details to be reviewed by the CI prior to inclusion).
* Currently pregnant, breast feeding, or on planned pregnancy.
* Medication intake (such as beta-blocker, glucocorticoids, anti-depressants, anti-inflammatory drugs in the last 7d).
* Medication intake (such as beta-blocker, glucocorticoids, anti-depressants) in the last 7d that are likely to affect brain function.
* Significant use of medication or recreational drugs that affect the nervous system.
* Excessive consumption of alcohol (\>2 alcohol beverages per day).
* Known allergy to any required consumables (such as aquasonic gel).
* History of anaphylaxis to any substance
* Have tightly coiled, curly or voluminous texture hair type (e.g., hair type 3, 4, or afro hair).
* Having skin disease or sensitive skin on or close to the head.
Source: ClinicalTrials.gov (NCT07671079). StuddyBuddy aggregates publicly available trial information.