Healthy ParticipantsNCT04168086
Cerebellar Functions in Visuomotor Adaptation
A study testing Focused Ultrasound in people with Healthy Participants, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Focused Ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult subjects
- 18 to 35 years of age
- Right-handed
- Provide written informed consent
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Sarah Adams, 434-243-4319, neuromodlab@hscmail.mcc.virginia.edu
About this study
Official title: Dissecting Cerebellar Functions in Visuomotor Adaptation With Transcranial Focused Ultrasound Stimulation
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Focused Ultrasound, Sham
- Keywords
- Ultrasound, Neuromodulation, Cerebellum, Transcranial Ultrasound Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundOther
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
ShamOther
The investigators will simulate focused ultrasound stimulation similar to the experimental groups but without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Right Motor Area Cerebellum | Experimental | Participants will receive Focused Ultrasound stimulation to motor area of the right cerebellum prior to completing a motor learning task. Receives: Other: Focused Ultrasound |
| Non-Motor Area Cerebellum | Experimental | Participants will receive Focused Ultrasound stimulation to a non-motor area of the right cerebellum prior to completing a motor learning task. Receives: Other: Focused Ultrasound |
| Control | Sham comparator | Participants will have the Focused Ultrasound transducer placed on their neck without stimulation as a Sham present prior to completing a motor learning task. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Error on Visuomotor Task
The visuomotor task has practice, baseline, and experimental trials. Performance on the task will be compared between groups.
Measured: baseline, immediately after FUS, and 30 minutes after FUS
Secondary outcomes (1)
Changes in Motor Evoked Potentials (MEP)
MEPs will be taken at baseline and throughout the task to assess effects ultrasound stimulation has on MEPs.
Measured: baseline, immediately after FUS, 10 minutes after FUS, and 20 minutes after FUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start28 Jan 2019
- Primary completion27 Jan 2020 (estimated)
- Study completion27 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wynn Legon, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168086
- Sponsor's protocol ID
- 21135
- Status last verified
- Nov 2019
- First submitted
- 19 Mar 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting Cerebellar Functions in Visuomotor Adaptation With Transcranial Focused Ultrasound Stimulation
- ClinicalTrials.gov ID
- NCT04168086
- Acronym / sponsor ID
- 21135
- Conditions
- Healthy Participants
- Keywords
- Ultrasound, Neuromodulation, Cerebellum, Transcranial Ultrasound Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 27 Jan 2020 (estimated)
- Study completion
- 27 Jan 2020 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right Motor Area Cerebellum | Experimental | Other: Focused UltrasoundParticipants will receive Focused Ultrasound stimulation to motor area of the right cerebellum prior to completing a motor learning task. |
| Non-Motor Area Cerebellum | Experimental | Other: Focused UltrasoundParticipants will receive Focused Ultrasound stimulation to a non-motor area of the right cerebellum prior to completing a motor learning task. |
| Control | Sham comparator | Other: ShamParticipants will have the Focused Ultrasound transducer placed on their neck without stimulation as a Sham present prior to completing a motor learning task. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, adult subjects
- 18 to 35 years of age
- Right-handed
- Provide written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused UltrasoundLow intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2 | Other | Non-Motor Area Cerebellum, Right Motor Area Cerebellum |
| ShamThe investigators will simulate focused ultrasound stimulation similar to the experimental groups but without stimulation. | Other | Control |
Primary outcome
Performance Error on Visuomotor Task
Time frame: baseline, immediately after FUS, and 30 minutes after FUS
The visuomotor task has practice, baseline, and experimental trials. Performance on the task will be compared between groups.
1 secondary outcome
Changes in Motor Evoked Potentials (MEP)
Time frame: baseline, immediately after FUS, 10 minutes after FUS, and 20 minutes after FUS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wynn Legon, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound in people with Healthy Participants, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Adams (434-243-4319, neuromodlab@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Error on Visuomotor Task (time frame: baseline, immediately after FUS, and 30 minutes after FUS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.