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

January 31, 2026 updated by: Mohammad Alkhawashki, University of Nottingham

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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
        • Precision Medical Imaging, QMC

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

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
FUS transducer is off, otherwise the process is the same
Procedure: Focused ultrasound
Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract.
Other Names:
  • FUS
  • tFUS
  • LIFUS
Diagnostic test: EEG
This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures
Active Comparator: Dentate
FUS parameters set to target dentate with pre-specified distance and intensity
Procedure: Focused ultrasound
Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract.
Other Names:
  • FUS
  • tFUS
  • LIFUS
Diagnostic test: EEG
This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures
Active Comparator: Superior cerebellar peduncle
FUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity
Procedure: Focused ultrasound
Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract.
Other Names:
  • FUS
  • tFUS
  • LIFUS
Diagnostic test: EEG
This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, peri-procedurally, on days 1, 2 and 3
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.
Through study completion, peri-procedurally, on days 1, 2 and 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Ataxia Rating Scale (BARS)
Time Frame: Through study completion, post-procedurally, on days 1, 2 and 3
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.
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
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
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
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.
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
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.
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
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.
Through study completion, post-procedurally, on days 1, 2 and 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Through study completion, pre-procedurally, on days 1, 2 and 3
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.
Through study completion, pre-procedurally, on days 1, 2 and 3
Subjective experience
Time Frame: Through study completion, post-procedurally, on days 1, 2 and 3
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.
Through study completion, post-procedurally, on days 1, 2 and 3
Blood Pressure
Time Frame: Through study completion, pre-procedurally, on days 1, 2 and 3
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.
Through study completion, pre-procedurally, on days 1, 2 and 3

Collaborators and Investigators

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

Sponsor

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)

February 5, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 6, 2025

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F1298R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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