Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07389447

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke Agency Brain Diseases CCAS Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Nervous System Diseases Trauma Vascular Diseases Verbal Memory Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Precision Medical Imaging, QMC

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focused Ultrasound

Procedure

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

Other names: FUS, tFUS, LIFUS

EEG

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study 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

Acronym: FUSCBM

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.