Agency, CCAS, Cognition, Stroke, Trauma, Verbal Memory
Conditions
Keywords
Cerebellum, Focused Ultrasound, Brain Stimulation, Computational Neuroscience, Neuroinformatics, White Matter, Grey Matter, Dentate Nucleus, Superior Cerebellar Peduncle, EEG, Power Band, Dynamics
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.
Interventions
PROCEDUREFocused ultrasound
Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract.
DIAGNOSTIC_TESTEEG
This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will receive a sham and two target stimulations in different orders.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalogram (EEG) power and spatiotemporal dynamics | 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. |
| Electrooculogram (EOG) power and spatiotemporal dynamics | 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Ataxia Rating Scale (BARS) | 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. |
| Cerebellar Cognitive Affective Syndrome Scale (CCASS) | 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 |
| n-Back Continuous performance task | 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. |
| Agency Task | 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. |
| Verbal Paired Associates (VPA) | 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. |
Countries
United Kingdom
Outcome results
None listed