Cognitive EnhancementNCT06829368
Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Participants
A study testing Transcranial Focused Ultrasound Stimulation in people with Cognitive Enhancement, run by University of Nottingham at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Enhancement
- What is being tested?
- Transcranial Focused Ultrasound Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2025to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neuromodulation Lab, Medical School, Queen's Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Enhancement
- Being tested
- Transcranial Focused Ultrasound Stimulation
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Focused Ultrasound StimulationOther
Using MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets.
| Study group | Role | What they receive |
|---|---|---|
| Mediodorsal Thalamus Stimulation | Active comparator | Theta-burst tFUS targeting the mediodorsal thalamus Receives: Other: Transcranial Focused Ultrasound Stimulation |
| Dorsal Anterior Cingulate Cortex Stimulation | Active comparator | Theta-burst tFUS targeting the dorsal anterior cingulate cortex Receives: Other: Transcranial Focused Ultrasound Stimulation |
| Anterior Insula Stimulation | Active comparator | Theta-burst tFUS targeting the anterior insula Receives: Other: Transcranial Focused Ultrasound Stimulation |
| Lateral Ventricle Stimulation | Sham comparator | Theta-burst tFUS targeting the lateral ventricle. Receives: Other: Transcranial Focused Ultrasound Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start20 Jan 2025
- Primary completion14 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive EnhancementStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Kaiser, University of Nottingham
- Investigators
- Marcus Kaiser, Professor of Neuroinformatics, Principal investigator, University of NottinghamMohammad Katshu, Clinical Associate Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829368
- Sponsor's protocol ID
- F1558
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Theta-Burst Transcranial Focused Ultrasound Stimulation to Enhance Cognition in Healthy Adults
- ClinicalTrials.gov ID
- NCT06829368
- Acronym / sponsor ID
- F1558
- Conditions
- Cognitive Enhancement
- Keywords
- Transcranial Ultrasound Stimulation, Theta-Burst Stimulation, Cognitive Enhancement, Visual Working Memory, EEG, Mediodorsal Thalamus, Anterior Cingulate Cortex, Anterior Insula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mediodorsal Thalamus Stimulation | Active comparator | Other: Transcranial Focused Ultrasound StimulationTheta-burst tFUS targeting the mediodorsal thalamus |
| Dorsal Anterior Cingulate Cortex Stimulation | Active comparator | Other: Transcranial Focused Ultrasound StimulationTheta-burst tFUS targeting the dorsal anterior cingulate cortex |
| Anterior Insula Stimulation | Active comparator | Other: Transcranial Focused Ultrasound StimulationTheta-burst tFUS targeting the anterior insula |
| Lateral Ventricle Stimulation | Sham comparator | Other: Transcranial Focused Ultrasound StimulationTheta-burst tFUS targeting the lateral ventricle. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Focused Ultrasound StimulationUsing MRI neuronavigation, the investigators will implement theta-burst tFUS in one of the four targets. | Other | Anterior Insula Stimulation, Dorsal Anterior Cingulate Cortex Stimulation, Lateral Ventricle Stimulation, Mediodorsal Thalamus Stimulation |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Kaiser, Professor of Neuroinformatics principal investigator
University of Nottingham
Mohammad Katshu, Clinical Associate Professor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Focused Ultrasound Stimulation in people with Cognitive Enhancement, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.