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

NCT07389447 | Active Not Recruiting

• 1 other identifier: F1298R
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (5)

• Brief Ataxia Rating Scale (BARS)

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

• Cerebellar Cognitive Affective Syndrome Scale (CCASS)

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

• n-Back Continuous performance task

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

• Agency Task

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

• Verbal Paired Associates (VPA)

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

Other Outcomes (3)

• Heart rate

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

• Subjective experience

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

• Blood Pressure

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

Study Arms (3)

Sham

SHAM COMPARATOR

FUS transducer is off, otherwise the process is the same

Procedure: Focused ultrasound; Diagnostic Test: EEG

Dentate

ACTIVE COMPARATOR

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

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

Procedure: Focused ultrasound; Diagnostic Test: EEG

Interventions

EEG DIAGNOSTIC_TEST

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

Dentate; Sham; Superior cerebellar peduncle

Focused ultrasound PROCEDURE

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

Also known as: FUS, tFUS, LIFUS

Dentate; Sham; Superior cerebellar peduncle

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Precision Medical Imaging, QMC

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Wounds and Injuries

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants will receive a sham and two target stimulations in different orders.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: February 5, 2026
• Study Start: February 5, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

GB (1)