Clinical trial NCT04168086: Cerebellar Functions in Visuomotor Adaptation
Official title: Dissecting Cerebellar Functions in Visuomotor Adaptation With Transcranial Focused Ultrasound Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Participants
Keywords: Ultrasound
Neuromodulation
Cerebellum
Transcranial Ultrasound Stimulation
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial focused ultrasound stimulation (tFUS) will be used in this study to functions of the cerebellum in human motor learning. Participants will complete a visuomotor task while receiving stimulation pulses from tFUS. How tFUS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy.

Detailed description: The purpose of this study is to test functions of the cerebellum in human motor learning. The cerebellum has been thought to play critical roles in human motor control and motor learning. Non-invasive brain stimulation studies with transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) provided evidence for the involvement of the cerebellum in human motor learning. However, due to limitations in spatial resolution of tDCS and TMS stimulation, it is still unclear what specific functions the cerebellum may have in motor learning, considering the behavioral and anatomical evidence that the cerebellum also has connections with prefrontal cortex and is associated with cognitive functions. By applying transcranial focused ultrasound stimulation (tFUS), which is a non-invasive brain stimulation technology with great spatial precision, the investigators aim to dissect functions of motor area and non-motor area of the cerebellum in motor learning. Young healthy adults will be recruited and randomly assigned to one of three experimental groups. During learning to adapt to a visual rotation (45 degrees) when reaching for a virtual target, subjects will receive tFUS stimulation over motor area of the cerebellum or non-motor area of the cerebellum depending on the study group. How tFUS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy.

Eligibility criteria: Inclusion Criteria:

* Healthy, adult subjects
* 18 to 35 years of age
* Right-handed
* Provide written informed consent

Exclusion Criteria:

* Presence of a psychiatric or neurologic illness
* History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
* Personal or family history of seizure
* Any history of stroke/transient ischemic attack (TIA) or severe traumatic brain injury
* Taking any medications that may decrease the threshold for seizure
* Pregnancy (self-reported)
* Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI
* Have any type of metal in the body
* Failure to follow laboratory or study procedures

Primary outcomes:
measure: Performance Error on Visuomotor Task
timeFrame: baseline, immediately after FUS, and 30 minutes after FUS
Secondary outcomes:
measure: Changes in Motor Evoked Potentials (MEP)
timeFrame: baseline, immediately after FUS, 10 minutes after FUS, and 20 minutes after FUS
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Wynn Legon, PhD
role: PRINCIPAL_INVESTIGATOR
References: