Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT06829368
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-02-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Participants
Sponsor:
University of Nottingham
Organization:
Study Overview
Official Title:
Using Theta-Burst Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examines the impact of theta-burst transcranial focused ultrasound stimulation (tFUS) on cognitive performance in healthy participants, specifically focusing on both acute and post-stimulation effects on visual working memory (vWM). The investigation will compare TUS effects across targeted deep cortical and subcortical brain regions involved in cognitive processing. Neurophysiological changes following stimulation will be assessed using EEG, providing insight into tFUS-induced modulations in working memory-related brain activity.
Detailed Description:
This single-blind, crossover trial investigates the effects of theta-burst transcranial focused ultrasound stimulation (tFUS) on visual working memory (vWM) in healthy participants. The study aims to evaluate cognitive enhancement by selectively targeting and comparing three brain structures associated with cognition: (1) the mediodorsal thalamus, (2) the dorsal anterior cingulate cortex, and (3) the anterior insula. Additionally, the lateral ventricle serves as a sham control target.
Each participant will attend four sessions, with each session dedicated to one of the brain structures or the sham site. Sessions consist of three distinct phases: (1) a pre-stimulation phase (task completion prior to tFUS), (2) an on-stimulation phase (task completion concurrent with tFUS), and (3) a post-stimulation phase (task completion following tFUS, with EEG recording). The Object in Place task will be used to assess vWM, requiring participants to recall the colour of abstract objects based on their location or shape.
Primary outcomes focus on both immediate (acute) and delayed (post-stimulation) behavioural changes in task performance, as well as neurophysiological EEG markers indicative of working memory processes. Moreover, the investigators will monitor for immediate and longer-term side effects. Stimulation is administered in a theta-burst pattern for 5 minutes, covering a portion of the task trials during the on-stimulation phase.
This study compares tFUS effects across various deep cortical and subcortical structures, examining acute and post-stimulation cognitive changes and monitoring immediate and longer-term side effects. Findings are expected to offer new insights into the potential of tFUS-based neuromodulation as a tool for cognitive enhancement.
Each participant will attend four sessions, with each session dedicated to one of the brain structures or the sham site. Sessions consist of three distinct phases: (1) a pre-stimulation phase (task completion prior to tFUS), (2) an on-stimulation phase (task completion concurrent with tFUS), and (3) a post-stimulation phase (task completion following tFUS, with EEG recording). The Object in Place task will be used to assess vWM, requiring participants to recall the colour of abstract objects based on their location or shape.
Primary outcomes focus on both immediate (acute) and delayed (post-stimulation) behavioural changes in task performance, as well as neurophysiological EEG markers indicative of working memory processes. Moreover, the investigators will monitor for immediate and longer-term side effects. Stimulation is administered in a theta-burst pattern for 5 minutes, covering a portion of the task trials during the on-stimulation phase.
This study compares tFUS effects across various deep cortical and subcortical structures, examining acute and post-stimulation cognitive changes and monitoring immediate and longer-term side effects. Findings are expected to offer new insights into the potential of tFUS-based neuromodulation as a tool for cognitive enhancement.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: