StrokeFUSCBMNCT07389447
Focused Ultrasound Stimulation of the Cerebellum to Induce Changes in Cognition and Brain Activity
A study testing Focused ultrasound and EEG in people with Stroke and Trauma, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The goal of this preclinical study is to assess the effects of focused ultrasound stimulation to the cerebellum on brain dynamics and cognition in healthy volunteers aged 18 to 40. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Focused ultrasound and EEG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Participants must not have claustrophobia or anxiety regarding MRI scan.
- Participants must not have current or planned pregnancy.
- Participants must not have history of neurological or psychiatric disorder.
- Participants must not have predisposition for fainting spells (syncope).
- Participants must not have implanted material (e.g., pacemaker, neurostimulator, medication infusion device, cochlear implants).
- Participants must not have medical patch that cannot or may not be taken off (e.g., nicotine patch).
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- Participants must not be currently taking psychoactive medication, or must have stopped taking such medication for at least 2 weeks before starting experiment (excluding contraception).
- Participants must not have skin disease on or close to the scalp.
- Participants must not have direct relatives (parents, siblings, children) with epilepsy, convulsion, or seizure.
- Participants must abstain from the use of any recreational drugs in the 48-hour period prior to taking part in the experiment.
- Participants must not consume more than 4 alcoholic units within the 24-hour period before participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Precision Medical Imaging, QMC
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: FUS of the Dentate Nucleus and Superior Cerebellar Peduncle of the Cerebellum Induces Changes to EEG Power Bands, Spatiotemporal Dynamics, and Cognitive Function in Healthy Humans
The goal of this preclinical study is to assess the effects of focused ultrasound stimulation to the cerebellum on brain dynamics and cognition in healthy volunteers aged 18 to 40. The main questions it aims to answer are:
Does FUS applied to the cerebellum affect cognition?
Does FUS applied to the white matter or gray matter of the cerebellum with the same parameters result in different outcomes?
Researchers will compare active and sham stimulations.
Participants will be asked to complete cognitive tasks after receiving FUS to the cerebellum.
- Being tested
- Focused ultrasound, EEG
- Keywords
- Cerebellum, Focused Ultrasound, Brain Stimulation, Computational Neuroscience, Neuroinformatics, White Matter, Grey Matter, Dentate Nucleus, Superior Cerebellar Peduncle, EEG, Power Band, Dynamics
- Medical subject headings
- Stroke, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused ultrasoundProcedure or surgery
Also called FUS, tFUS, LIFUS
Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract.
EEGDiagnostic test
This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | FUS transducer is off, otherwise the process is the same Receives: Procedure: Focused ultrasound; Diagnostic Test: EEG |
| Dentate | Active comparator | FUS parameters set to target dentate with pre-specified distance and intensity Receives: Procedure: Focused ultrasound; Diagnostic Test: EEG |
| Superior cerebellar peduncle | Active comparator | FUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity Receives: Procedure: Focused ultrasound; Diagnostic Test: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG) power and spatiotemporal dynamics
The investigators measure the changes in EEG power in delta, theta, alpha, beta and gamma band, and spatiotemporal dynamics while administering concurrent transcranial focused ultrasound stimulation (tFUS). The EEG will also be used to asses network changes during sonication.
Measured: Through study completion, peri-procedurally, on days 1, 2 and 3
Electrooculogram (EOG) power and spatiotemporal dynamics
The investigators measure the ocular saccades from both frontal head electrodes and electrodes places by the sides of the eyes while administering concurrent tFUS. This data will be used for identifying and removing eye-movement artifacts from EEG and assess eye saccades during sonication. This will be applied to some of the participants but not all, due to availability.
Measured: Through study completion, peri-procedurally, on days 1, 2 and 3
Secondary outcomes (5)
Brief Ataxia Rating Scale (BARS)
The investigators measure BARS out of a total score of 30. A score of 0 means that the participant experiences no motor deficits of cerebellar origin, whereas a score of 30 means that the participant is highly ataxic.
Measured: Through study completion, post-procedurally, on days 1, 2 and 3
Cerebellar Cognitive Affective Syndrome Scale (CCASS)
The investigators measure CCASS out of a total score of 120, or an absolute score that isn't limited, where a higher score is a better outcome
Measured: Through study completion, post-procedurally, on days 1, 2 and 3
n-Back Continuous performance task
The investigators measure working memory with a game that involves remembering the last letter shown, with the "n" in n-Back denoting how many letters back the memorised letter was shown.
Measured: Through study completion, post-procedurally, on days 1, 2 and 3
Agency Task
The investigators measure participant's sense of agency through a game which involves the participant assessing their level of control and performance. the score is calculated from how well the participant matches their assessment to the game's assessment.
Measured: Through study completion, post-procedurally, on days 1, 2 and 3
Verbal Paired Associates (VPA)
The investigators measure a participant's ability to remember the second word in a set of word pairs. The score is out of a total of 48, but calculations are done to assess performance over repetitions and time.
Measured: Through study completion, post-procedurally, on days 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start5 Feb 2024
- Primary completion31 Dec 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive a sham and two target stimulations in different orders.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Alkhawashki, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389447
- Sponsor's protocol ID
- F1298R
- Acronym
- FUSCBM
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUS of the Dentate Nucleus and Superior Cerebellar Peduncle of the Cerebellum Induces Changes to EEG Power Bands, Spatiotemporal Dynamics, and Cognitive Function in Healthy Humans
- ClinicalTrials.gov ID
- NCT07389447
- Acronym / sponsor ID
- FUSCBM / F1298R
- Keywords
- Cerebellum, Focused Ultrasound, Brain Stimulation, Computational Neuroscience, Neuroinformatics, White Matter, Grey Matter, Dentate Nucleus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
The goal of this preclinical study is to assess the effects of focused ultrasound stimulation to the cerebellum on brain dynamics and cognition in healthy volunteers aged 18 to 40. The main questions it aims to answer are:
Does FUS applied to the cerebellum affect cognition?
Does FUS applied to the white matter or gray matter of the cerebellum with the same parameters result in different outcomes?
Researchers will compare active and sham stimulations.
Participants will be asked to complete cognitive tasks after receiving FUS to the cerebellum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will receive a sham and two target stimulations in different orders.
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Procedure: Focused ultrasound, Diagnostic Test: EEGFUS transducer is off, otherwise the process is the same |
| Dentate | Active comparator | Procedure: Focused ultrasound, Diagnostic Test: EEGFUS parameters set to target dentate with pre-specified distance and intensity |
| Superior cerebellar peduncle | Active comparator | Procedure: Focused ultrasound, Diagnostic Test: EEGFUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Participants must not have claustrophobia or anxiety regarding MRI scan.
- Participants must not have current or planned pregnancy.
- Participants must not have history of neurological or psychiatric disorder.
- Participants must not have predisposition for fainting spells (syncope).
- Participants must not have implanted material (e.g., pacemaker, neurostimulator, medication infusion device, cochlear implants).
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 |
|---|---|---|
| Focused ultrasoundAlso: FUS, tFUS, LIFUSFocused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract. | Procedure or surgery | Dentate, Sham, Superior cerebellar peduncle |
| EEGThis is the electroencephalography reading that will show changes in brain activity as describes in outcome measures | Diagnostic test | Dentate, Sham, Superior cerebellar peduncle |
Primary outcome
Electroencephalogram (EEG) power and spatiotemporal dynamics
Time frame: Through study completion, peri-procedurally, on days 1, 2 and 3
The investigators measure the changes in EEG power in delta, theta, alpha, beta and gamma band, and spatiotemporal dynamics while administering concurrent transcranial focused ultrasound stimulation (tFUS). The EEG will also be used to asses network changes during sonication.
Electrooculogram (EOG) power and spatiotemporal dynamics
Time frame: Through study completion, peri-procedurally, on days 1, 2 and 3
The investigators measure the ocular saccades from both frontal head electrodes and electrodes places by the sides of the eyes while administering concurrent tFUS. This data will be used for identifying and removing eye-movement artifacts from EEG and assess eye saccades during sonication. This will be applied to some of the participants but not all, due to availability.
5 secondary outcomes
Brief Ataxia Rating Scale (BARS)
Time frame: Through study completion, post-procedurally, on days 1, 2 and 3
Cerebellar Cognitive Affective Syndrome Scale (CCASS)
Time frame: Through study completion, post-procedurally, on days 1, 2 and 3
n-Back Continuous performance task
Time frame: Through study completion, post-procedurally, on days 1, 2 and 3
Agency Task
Time frame: Through study completion, post-procedurally, on days 1, 2 and 3
Verbal Paired Associates (VPA)
Time frame: Through study completion, post-procedurally, on days 1, 2 and 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused ultrasound and EEG in people with Stroke and Trauma, 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 0 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
Electroencephalogram (EEG) power and spatiotemporal dynamics (time frame: Through study completion, peri-procedurally, on days 1, 2 and 3). 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 5 Feb 2026.