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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | FUS transducer is off, otherwise the process is the same |
|
| Dentate | Active Comparator | FUS parameters set to target dentate with pre-specified distance and intensity |
|
| Superior cerebellar peduncle | Active Comparator | FUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused ultrasound | Procedure | Focused ultrasound stimulation administered to the cerebellar nucleus or efferent fiber tract. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Ataxia Rating Scale (BARS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | 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 |
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Precision Medical Imaging, QMC | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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Participants will receive a sham and two target stimulations in different orders.
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|
| EEG | Diagnostic Test | This is the electroencephalography reading that will show changes in brain activity as describes in outcome measures |
|
| Cerebellar Cognitive Affective Syndrome Scale (CCASS) |
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 | 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 | 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) | 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 |
| Subjective experience | 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 | 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |