Focused UltrasoundNCT04192149
The Effects of Ultrasound on Central Nervous System
A study testing Focused Ultrasound in people with Focused Ultrasound, run by University of Virginia at 1 site in United States.
Trial summary
Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Focused Ultrasound
- What is being tested?
- Focused Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to 20 Feb 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a patient receiving a treatment or surgical procedure specified below:
- Receiving a Craniotomy with brain mapping
- Receiving treatment or monitoring for Epilepsy
- Receiving either FUS or DBS treatment for Tremor
- Receiving a Spinal Surgery for stimulator placement
- Able to provide informed consent
- Must speak English
- Age 18-85
Who cannot join
- Not receiving one of the specified inclusion procedures
- Unable to provide consent
- Women who self-report pregnancy
- Patients who are currently incarcerated
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
Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. The purpose of this study is to better understand the effects of low intensity focused ultrasound (FUS) on the central nervous system. Specific patient populations within UVA health system are undergoing treatment that provide unique opportunities to study these effects.
Read the detailed description
Focused ultrasound (FUS) at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. In this study the investigators intended to use specific patient populations to investigate the effects of FUS on different areas of the central nervous system (CNS). Each of our patients groups is undergoing a unique procedure at University of Virginia that will provide us different insights into the CNS. (1) Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive FUS mapping. (2) Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of FUS stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. (3) Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity FUS research procedure and changes in their tremor will be monitored. (4) Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive FUS stimulation observed through their newly implanted electrode. (5) Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive FUS stimulation.
- Conditions
- Focused Ultrasound
- Being tested
- Focused Ultrasound
- Keywords
- Ultrasound, Neuromodulation, Focused Ultrasound
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
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Craniotomy | Experimental | Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive Focused Ultrasound mapping. Receives: Other: Focused Ultrasound |
| Epilepsy Patients | Experimental | Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of Focused Ultrasound stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. Receives: Other: Focused Ultrasound |
| Tremor Patients receiving FUS | Experimental | Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity Focused Ultrasound research procedure and changes in their tremor will be monitored. Receives: Other: Focused Ultrasound |
| Tremor Patients receiving DBS | Experimental | Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive Focused Ultrasound stimulation observed through their newly implanted electrode. Receives: Other: Focused Ultrasound |
| Patients receiving Spinal Surgery | Experimental | Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive Focused Ultrasound stimulation. Receives: Other: Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological Changes as a result of Ultrasound
Each participant group has different type of electrophysiological recording depending on the type of procedure. Recordings will include a baseline, during ultrasound, and/or post-ultrasound electrophysiology.
Measured: baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start19 Feb 2019
- Primary completion20 Feb 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focused UltrasoundStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Within subjects design of focused ultrasound and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 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
- NCT04192149
- Sponsor's protocol ID
- 21331
- Status last verified
- Dec 2019
- First submitted
- 19 Mar 2019
- Last updated
- 10 Dec 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound on Central Nervous System
- ClinicalTrials.gov ID
- NCT04192149
- Acronym / sponsor ID
- 21331
- Conditions
- Focused Ultrasound
- Keywords
- Ultrasound, Neuromodulation, Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 20 Feb 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 10 Dec 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.
Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. The purpose of this study is to better understand the effects of low intensity focused ultrasound (FUS) on the central nervous system. Specific patient populations within UVA health system are undergoing treatment that provide unique opportunities to study these effects.
Detailed description
Focused ultrasound (FUS) at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. In this study the investigators intended to use specific patient populations to investigate the effects of FUS on different areas of the central nervous system (CNS). Each of our patients groups is undergoing a unique procedure at University of Virginia that will provide us different insights into the CNS. (1) Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive FUS mapping. (2) Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of FUS stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. (3) Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity FUS research procedure and changes in their tremor will be monitored. (4) Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive FUS stimulation observed through their newly implanted electrode. (5) Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive FUS stimulation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Within subjects design of focused ultrasound and control
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Craniotomy | Experimental | Other: Focused UltrasoundPatients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive Focused Ultrasound mapping. |
| Epilepsy Patients | Experimental | Other: Focused UltrasoundPatients undergoing long term monitoring for epilepsy will receive a non-invasive form of Focused Ultrasound stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. |
| Tremor Patients receiving FUS | Experimental | Other: Focused UltrasoundPatients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity Focused Ultrasound research procedure and changes in their tremor will be monitored. |
| Tremor Patients receiving DBS | Experimental | Other: Focused UltrasoundPatients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive Focused Ultrasound stimulation observed through their newly implanted electrode. |
| Patients receiving Spinal Surgery | Experimental | Other: Focused UltrasoundPatients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive Focused Ultrasound stimulation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be a patient receiving a treatment or surgical procedure specified below:
- Receiving a Craniotomy with brain mapping
- Receiving treatment or monitoring for Epilepsy
- Receiving either FUS or DBS treatment for Tremor
- Receiving a Spinal Surgery for stimulator placement
Key exclusion criteria (4 listed)
- Not receiving one of the specified inclusion procedures
- Unable to provide consent
- Women who self-report pregnancy
- Patients who are currently incarcerated
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 | Epilepsy Patients, Patients receiving Craniotomy, Patients receiving Spinal Surgery, Tremor Patients receiving DBS, Tremor Patients receiving FUS |
Primary outcome
Electrophysiological Changes as a result of Ultrasound
Time frame: baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)
Each participant group has different type of electrophysiological recording depending on the type of procedure. Recordings will include a baseline, during ultrasound, and/or post-ultrasound electrophysiology.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 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 Focused Ultrasound, 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 8 inclusion and 4 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 10 Dec 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. 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 (434-243-4239, 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?
Electrophysiological Changes as a result of Ultrasound (time frame: baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)). 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 10 Dec 2019.