临床试验/NCT07671079

NCT07671079尚未招募不适用

Closed-loop Non-invasive Stimulation for Improving Brain and Mental Health in Healthy Individuals

University of Nottingham1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2026年9月1日最近更新: 2026年8月19日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: University of Nottingham
入组人数: 30
试验地点: 1
主要终点: Change from Baseline in EEG Power in Alpha Band (8-12Hz)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

Closed-loop approaches may offer greater efficacy and lower variability across individuals compared to current open-loop stimulation approaches, yet they remain a relatively new approach, with no studies evaluating closed-loop transcranial low-intensity focused ultrasound stimulation (FUS) yet.

For this reason, we will collect and evaluate cognitive, biological and metabolic data from healthy participants, before and after closed-loop and open-loop stimulation interventions. This will allow us to compare our proposed closed-loop stimulation approach to stablished non-invasive techniques and to investigate the underlying mechanisms through which FUS can alter brain activity.

For this study, participants will attend multiple visits. To assess eligibility, participants will attend one initial session in-person before the start of the study.

Following safety guidelines, each participant will receive a maximum of two 1-hour MRI scanning sessions in a single week.

This study will be separated into two blocks of stimulation sessions: one block for tACS-FUS, and another block for TI-FUS. Participants will be randomly allocated to receive one of the blocks.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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 antidepressants, antipsychotics, anti-epileptics, beta blockers, glucocorticoids, anti-inflammatories, benzodiazepines, hypnotics, sedating antihistamines or any illicit substances in the past seven days).
•Significant use of medication or recreational drugs that affect the nervous system.
•Excessive consumption of alcohol.
•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.

研究组 & 干预措施

Open-loop transcranial low-intensity FUS

Active Comparator

Transcranial low intensity focused ultrasound stimulation (FUS) with 500kHz transducer for following either the continuous theta burst or intermittent theta burst protocol using the NeuroFus PRO system

干预措施: Transcranial low intensity focused ultrasound (FUS) (Other)

Open-loop transcranial low-intensity FUS

Active Comparator

干预措施: Magnetic Resonance Imaging (Procedure)

Closed-loop transcranial low-intensity FUS

Experimental

Closed-loop Transcranial Electrical Stimulation by means of tACS or TI delivered through a Digitimer DS5 for brain entrainment phase-locked on peak or trough to transcranial low intensity FUS delivered to dACC through the NeuroFUS PRO system

干预措施: Magnetic Resonance Imaging (Procedure)

tES alone

Active Comparator

tACS or TI delivered through a Digitimer DS5 for brain entrainment phase-locked on peak or trough

干预措施: transcranial electrical stimulation (Other)

tES alone

Active Comparator

tACS or TI delivered through a Digitimer DS5 for brain entrainment phase-locked on peak or trough

干预措施: Magnetic Resonance Imaging (Procedure)

Sham FUS

Active Comparator

FUS delivered to ventricles or FUS and tACS located on head, one of them on or off depending on sham, or active.

干预措施: Transcranial low intensity focused ultrasound (FUS) (Other)

Sham FUS

Active Comparator

FUS delivered to ventricles or FUS and tACS located on head, one of them on or off depending on sham, or active.

干预措施: Magnetic Resonance Imaging (Procedure)

Closed-loop transcranial low-intensity FUS

Experimental

干预措施: Transcranial low intensity focused ultrasound (FUS) (Other)

Closed-loop transcranial low-intensity FUS

Experimental

干预措施: transcranial electrical stimulation (Other)