Ultrasound in MRINCT03634631
Effects of Transcranial Focused Ultrasound on Human Primary Motor Cortex Using 7T fMRI
A study testing Focused Ultrasound in people with Ultrasound in MRI, run by University of Minnesota.
Trial summary
Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single element transducer to produce highly focused low-intensity acoustic energy that can be used to affect cortical excitability in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound in MRI
- What is being tested?
- Focused Ultrasound
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 11 Aug 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age Provide written informed consent
Who cannot join
- Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder 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) Taking any medications that may decrease the threshold for seizure Pregnancy 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 Failure to follow laboratory or study procedures
About this study
Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single element transducer to produce highly focused low-intensity acoustic energy that can be used to affect cortical excitability in humans. This technology has an advantage over existing electric and electromagnetic technologies in that it has very high spatial resolution and can be focused deep to the cortical surface to target sub-cortical neural structures and circuits. Previous research has shown that tFUS can affect human tactile detection thresholds (Legon et al. 2014a) as well as functional measures of the electroencephalogram (EEG) (Legon et al. 2014a; Mueller et al. 2014a). However, EEG does not provide for detailed spatial mappings and thus the specific spatial extent of the effect of acoustic energy in the cortex is not yet understood. This is an important consideration for the advancement of tFUS as a non-surgical method of stimulation of discrete cortical circuits and small sub-cortical neural structures. Is the effect of tFUS limited to its beam maxima? Does the effect extend along the beam path? And if so, to what extent? These questions can be answered if tFUS is combined with magnetic resonance imaging (MRI).
Read the detailed description
Background and Significance:
MRI provides highly detailed spatial maps of cortical and sub-cortical activation. As such, delivering tFUS in the MR scanner can provide critical information on neural activation as a result of tFUS. It is unclear however, if tFUS can generate a detectable blood-oxygen level dependent (BOLD) response. Preliminary evidence in humans (Mueller et al. 2014b; Legon et al. 2015) has demonstrated mostly negative results and highly variable responses perhaps due to the transducer or acoustic intensity levels used, the pulsing strategy employed and/or poor signal to noise ratios. We know from animal work it is possible to detect a change in BOLD response from tFUS if a known signal already exists. Yoo et al. (2011) showed focused ultrasound to attenuate the BOLD signal generated by visual stimuli in visual cortex of rabbits. Thus, it is reasonable to assume that this effect is transferable to humans as the underlying brain physiology producing the BOLD signal is the same.
Here we plan to investigate the effect of tFUS on the BOLD signal in human primary motor (M1). M1 has been chosen for two fundamental reasons. 1) The use of muscle contraction to generate a BOLD signal in M1 allows for investigation tFUS on the peripheral electromyogram (EMG) and 2) spatially specific BOLD responses in the cortex can be generated depending upon the musculature used, thus allowing for precise spatial mapping of effect. The first point is of significant interest because if a detectable effect is demonstrated on peripheral musculature it provides important initial evidence that tFUS operates on cortical motor neurons and descending motor tracts similar to electric and electromagnetic stimulation thus hinting at the cellular populations and mechanisms affected by and responsible for tFUS neuromodulatory effect. The second point confirms with high precision the spatially selective effect of tFUS and if we can establish energy/effect functions from this data, this can also lead to scaling of tFUS energies to elicit specific effects such as inhibition or excitation.
Together, this knowledge will further promote tFUS for cortical stimulation and progress tFUS for subcortical stimulation in humans. This last advancement is the great potential of tFUS. Imagine a small device that can simply be attached to the head for precise stimulation anywhere in the brain in lieu of surgery. This is the ultimate goal of this research, however, before this can be considered, the detailed data from this research proposal is necessary.
- Conditions
- Ultrasound in MRI
- Being tested
- Focused Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundOther
Test ultrasound in 7T MRI scanner
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary motor cortex BOLD signal
Primary motor cortex BOLD signal
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jan 2017
- Primary completion11 Aug 2018
- Study completion11 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound in MRIStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634631
- Sponsor's protocol ID
- 1508M77355
- Status last verified
- Jul 2019
- First submitted
- 14 Aug 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ai L, Bansal P, Mueller JK, Legon W. Effects of transcranial focused ultrasound on human primary motor cortex using 7T fMRI: a pilot study. BMC Neurosci. 2018 Sep 14;19(1):56. doi: 10.1186/s12868-018-0456-6.
PubMed 30217150
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Focused Ultrasound on Human Primary Motor Cortex Using 7T fMRI
- ClinicalTrials.gov ID
- NCT03634631
- Acronym / sponsor ID
- 1508M77355
- Conditions
- Ultrasound in MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 11 Aug 2018 (actual)
- First posted
- 16 Aug 2018 (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 (tFUS) is a form of neuromodulation that uses a single element transducer to produce highly focused low-intensity acoustic energy that can be used to affect cortical excitability in humans. This technology has an advantage over existing electric and electromagnetic technologies in that it has very high spatial resolution and can be focused deep to the cortical surface to target sub-cortical neural structures and circuits. Previous research has shown that tFUS can affect human tactile detection thresholds (Legon et al. 2014a) as well as functional measures of the electroencephalogram (EEG) (Legon et al. 2014a; Mueller et al. 2014a). However, EEG does not provide for detailed spatial mappings and thus the specific spatial extent of the effect of acoustic energy in the cortex is not yet understood. This is an important consideration for the advancement of tFUS as a non-surgical method of stimulation of discrete cortical circuits and small sub-cortical neural structures. Is the effect of tFUS limited to its beam maxima? Does the effect extend along the beam path? And if so, to what extent? These questions can be answered if tFUS is combined with magnetic resonance imaging (MRI).
Detailed description
Background and Significance:
MRI provides highly detailed spatial maps of cortical and sub-cortical activation. As such, delivering tFUS in the MR scanner can provide critical information on neural activation as a result of tFUS. It is unclear however, if tFUS can generate a detectable blood-oxygen level dependent (BOLD) response. Preliminary evidence in humans (Mueller et al. 2014b; Legon et al. 2015) has demonstrated mostly negative results and highly variable responses perhaps due to the transducer or acoustic intensity levels used, the pulsing strategy employed and/or poor signal to noise ratios. We know from animal work it is possible to detect a change in BOLD response from tFUS if a known signal already exists. Yoo et al. (2011) showed focused ultrasound to attenuate the BOLD signal generated by visual stimuli in visual cortex of rabbits. Thus, it is reasonable to assume that this effect is transferable to humans as the underlying brain physiology producing the BOLD signal is the same.
Here we plan to investigate the effect of tFUS on the BOLD signal in human primary motor (M1). M1 has been chosen for two fundamental reasons. 1) The use of muscle contraction to generate a BOLD signal in M1 allows for investigation tFUS on the peripheral electromyogram (EMG) and 2) spatially specific BOLD responses in the cortex can be generated depending upon the musculature used, thus allowing for precise spatial mapping of effect. The first point is of significant interest because if a detectable effect is demonstrated on peripheral musculature it provides important initial evidence that tFUS operates on cortical motor neurons and descending motor tracts similar to electric and electromagnetic stimulation thus hinting at the cellular populations and mechanisms affected by and responsible for tFUS neuromodulatory effect. The second point confirms with high precision the spatially selective effect of tFUS and if we can establish energy/effect functions from this data, this can also lead to scaling of tFUS energies to elicit specific effects such as inhibition or excitation.
Together, this knowledge will further promote tFUS for cortical stimulation and progress tFUS for subcortical stimulation in humans. This last advancement is the great potential of tFUS. Imagine a small device that can simply be attached to the head for precise stimulation anywhere in the brain in lieu of surgery. This is the ultimate goal of this research, however, before this can be considered, the detailed data from this research proposal is necessary.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 65 years of age Provide written informed consent
Key exclusion criteria (1 listed)
- Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder 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) Taking any medications that may decrease the threshold for seizure Pregnancy 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 Failure to follow laboratory or study procedures
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 UltrasoundTest ultrasound in 7T MRI scanner | Other | – |
Primary outcome
Primary motor cortex BOLD signal
Time frame: 30 minutes
Primary motor cortex BOLD signal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 30217150Ai L, Bansal P, Mueller JK, Legon W. Effects of transcranial focused ultrasound on human primary motor cortex using 7T fMRI: a pilot study. BMC Neurosci. 2018 Sep 14;19(1):56. doi: 10.1186/s12868-018-0456-6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound in people with Ultrasound in MRI, run by University of Minnesota.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary motor cortex BOLD signal (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634631, which also lists 1 linked publication.
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 12 Jul 2019.