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Active, not recruitingNCT07389447FUSCBMUpdated Feb 5, 2026

Focused Ultrasound Stimulation of the Cerebellum to Induce Changes in Cognition and Brain Activity

An interventional study of Focused ultrasound and EEG in Stroke, Trauma and Cognition, sponsored by University of Nottingham. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Feb 2024, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke
  • Trauma
  • Cognition
  • Agency
  • Verbal Memory
  • CCAS

Keywords

  • Cerebellum
  • Focused Ultrasound
  • Brain Stimulation
  • Computational Neuroscience
  • Neuroinformatics
  • White Matter
  • Grey Matter
  • Dentate Nucleus
  • Superior Cerebellar Peduncle
  • EEG
  • Power Band
  • Dynamics
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Exclusion Criteria:

  • 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).
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Sham comparator
    Sham

    FUS transducer is off, otherwise the process is the same

    Procedure: Focused ultrasound · Diagnostic Test: EEG

  • Active comparator
    Dentate

    FUS parameters set to target dentate with pre-specified distance and intensity

    Procedure: Focused ultrasound · Diagnostic Test: EEG

  • Active comparator
    Superior cerebellar peduncle

    FUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity

    Procedure: Focused ultrasound · Diagnostic Test: EEG

Interventions

  • ProcedureFocused ultrasound

    Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract.

    Also known as: FUS, tFUS, LIFUS

  • Diagnostic testEEG

    This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, peri-procedurally, on days 1, 2 and 3

  2. 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.

    Time frame: Through study completion, peri-procedurally, on days 1, 2 and 3

Secondary outcomes

  1. 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.

    Time frame: Through study completion, post-procedurally, on days 1, 2 and 3

  2. 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

    Time frame: Through study completion, post-procedurally, on days 1, 2 and 3

  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.

    Time frame: Through study completion, post-procedurally, on days 1, 2 and 3

  4. 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.

    Time frame: Through study completion, post-procedurally, on days 1, 2 and 3

  5. 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.

    Time frame: Through study completion, post-procedurally, on days 1, 2 and 3

Other outcomes

  1. Heart rate

    Heart rate is measured to take a baseline reading prior to sonication. A stable heart rate between 60 and 80 bpm is favorable. A heart rate above 100 bpm or a low heart rate under 50 prompts us to reassess participant readiness. Heart rate is taken again post sonication only in case of adverse reaction.

    Time frame: Through study completion, pre-procedurally, on days 1, 2 and 3

  2. Subjective experience

    The participants will be questioned on their experience of the study and on any side effects they experience during or 24 hours after the stimulation. This isn't a scale but a questionnaire that has multiple measures such as sleepiness prior to experiment, and self reporting on adverse effects like dizziness or any other effects.

    Time frame: Through study completion, post-procedurally, on days 1, 2 and 3

  3. Blood Pressure

    Blood pressure is taken prior to sonication for baseline reading. A favorable reading falls within the normal range of 100/60 to 130/90. anything that falls outside of that range prompts reassessment of participant readiness. Blood pressure readings are taken again in case of any adverse reaction only.

    Time frame: Through study completion, pre-procedurally, on days 1, 2 and 3

07

Study locations

1 site
  • Precision Medical Imaging, QMC
    Nottingham, Nottinghamshire NG7 2UH, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07389447
Lead sponsor
University of Nottingham
Responsible party
Mohammad Alkhawashki (Dr, University of Nottingham) — Principal investigator
First posted
Feb 5, 2026
Start date
Feb 5, 2024
Primary completion
Dec 31, 2025
Completion
Jul 31, 2026 (estimated)
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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