Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Participants

NCT06829368 | Recruiting

• 1 other identifier: F1558
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Enhancement

Keywords

Transcranial Ultrasound Stimulation; Theta-Burst Stimulation; Cognitive Enhancement; Visual Working Memory; EEG; Mediodorsal Thalamus; Anterior Cingulate Cortex; Anterior Insula; Transcranial Focused Ultrasound Stimulation; Focused Ultrasound Stimulation; Low-Intensity Focused Ultrasound Stimulation

Outcome Measures

Primary Outcomes (2)

• Performance Change in Visual Working Memory Task

  Measuring behavioural change in the modified Object in Place Visual Working Memory task, assessed through accuracy and reaction time.

  Measured at three time points (pre-stimulation, on-stimulation, and post-stimulation) during each session. Each participant completes four sessions, occurring once per week over approximately 4 weeks.

• EEG Changes Post Stimulation

  Analysis of EEG markers associated with cognitive processes

  Measured at three time points (pre-stimulation, on-stimulation, and post-stimulation) during each session. Each participant completes four sessions, occurring once per week over approximately 4 weeks.

Study Arms (4)

Mediodorsal Thalamus Stimulation

ACTIVE COMPARATOR

Theta-burst tFUS targeting the mediodorsal thalamus

Other: Transcranial Focused Ultrasound Stimulation

Dorsal Anterior Cingulate Cortex Stimulation

ACTIVE COMPARATOR

Theta-burst tFUS targeting the dorsal anterior cingulate cortex

Other: Transcranial Focused Ultrasound Stimulation

Anterior Insula Stimulation

ACTIVE COMPARATOR

Theta-burst tFUS targeting the anterior insula

Other: Transcranial Focused Ultrasound Stimulation

Lateral Ventricle Stimulation

SHAM COMPARATOR

Theta-burst tFUS targeting the lateral ventricle.

Other: Transcranial Focused Ultrasound Stimulation

Interventions

Transcranial Focused Ultrasound Stimulation OTHER

Using MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets.

Anterior Insula Stimulation; Dorsal Anterior Cingulate Cortex Stimulation; Lateral Ventricle Stimulation; Mediodorsal Thalamus Stimulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-55years
• Healthy adults with no history of neurological or psychiatric disorders
• Eligible to undergo a T1-weighted MRI scan for tFUS neuronavigational purposes
• Ability to adhere to the tFUS study schedule and complete all assessments
• Right-handed
• Fluent in English
• Abstinence from the use of any recreational drugs in the 48-hour period prior to taking part in the experiment.
• Abstinence from consuming no more than 4 alcoholic units within the 24-hour period before participation.

You may not qualify if:

• Any current psychiatric diagnosis
• Neurodevelopmental disorders; history of central nervous system disease, concussion, or other neurological sequelae; presence of tumors, seizures, meningitis, encephalitis, or any abnormal MRI findings of the brain
• Use of any psychotropic medications within five half-lives before the procedure
• Presence of metal implants contraindicated for MRI
• History of head trauma with loss of consciousness
• Calcification in sonicated parts of the brain.
• Visual impairments that cannot be corrected with glasses
• Inability to complete cognitive testing requirements
• Active participation or plans for enrollment in other clinical trials that may impact psychosocial functioning
• History of repeated substance abuse or dependence (excluding nicotine and caffeine); use of medications such as stimulants, modafinil, thyroid medication, or steroids
• No skin disease on or close to the scalp.
• History of seizure or epilepsy; use of medications that lower seizure thresholds
• Claustrophobia or any other condition precluding MRI assessment
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Neuromodulation Lab, Medical School, Queen's Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Study Officials

• Marcus Kaiser, Professor of Neuroinformatics

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Mohammad Katshu, Clinical Associate Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanos A Kontogouris, PhD Student

CONTACT

+44 7826221912; stefanos.kontogouris@nottingham.ac.uk

Mohammad Alkhawashki, PhD Student

CONTACT

+44 7840540456; mohammad.alkhawashki@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The lateral ventricle is designated as the sham control site, given prior evidence that tFUS targeting this region elicits no detectable effects. This choice facilitates consistent participant expectations across sessions, enabling a reliable baseline comparison. To further reduce bias, participants are blinded to the specific brain region targeted in each session and unaware of whether the stimulation is active or sham. This methodological approach aims to prevent any performance adjustment based on presumed effects of the stimulation, thereby enhancing the validity of the results.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neuroinformatics

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 17, 2025
• Study Start: January 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-02

Locations

GB (1)