Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Participants

May 20, 2026 updated by: Marcus Kaiser, University of Nottingham

Using Theta-Burst Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Neuromodulation Lab, Medical School, Queen's Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mediodorsal Thalamus Stimulation
Theta-burst tFUS targeting the mediodorsal thalamus
Other: Transcranial Focused Ultrasound Stimulation
Using MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets.
Active Comparator: Dorsal Anterior Cingulate Cortex Stimulation
Theta-burst tFUS targeting the dorsal anterior cingulate cortex
Other: Transcranial Focused Ultrasound Stimulation
Using MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets.
Active Comparator: Anterior Insula Stimulation
Theta-burst tFUS targeting the anterior insula
Other: Transcranial Focused Ultrasound Stimulation
Using MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets.
Sham Comparator: Lateral Ventricle Stimulation
Theta-burst tFUS targeting the lateral ventricle.
Other: Transcranial Focused Ultrasound Stimulation
Using MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Change in Visual Working Memory Task
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Marcus Kaiser, Professor of Neuroinformatics, University of Nottingham
  • Principal Investigator: Mohammad Katshu, Clinical Associate Professor, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Actual)

March 14, 2026

Study Completion (Actual)

March 14, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • F1558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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