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

University of Nottingham

Status: Active, not recruiting

Conditions: CCAS; Agency; Stroke; Trauma; Cognition; Verbal Memory

Treatments: Diagnostic Test: EEG; Procedure: Focused ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07389447

F1298R

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Sham

Sham Comparator group

Description:

FUS transducer is off, otherwise the process is the same

Treatment:

Procedure: Focused ultrasound

Diagnostic Test: EEG

Dentate

Active Comparator group

Description:

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

Treatment:

Procedure: Focused ultrasound

Diagnostic Test: EEG

Superior cerebellar peduncle

Active Comparator group

Description:

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

Treatment:

Procedure: Focused ultrasound

Diagnostic Test: EEG