Somatic PainNCT06343883
Investigation of Low-intensity Focused Ultrasound Pressure
A study testing low-intensity focused ultrasound - low pressure, low-intensity focused ultrasound - medium pressure and low-intensity focused ultrasound - high pressure in people with Somatic Pain, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Somatic Pain
- What is being tested?
- low-intensity focused ultrasound - low pressure, low-intensity focused ultrasound - medium pressure and low-intensity focused ultrasound - high pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 31 Oct 2024
- 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
- Understand and speak English
Who cannot join
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- History of head injury resulting in loss of consciousness for >10 minutes.
- History of alcohol or drug dependence (through self-report).
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.
Read the detailed description
Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.
- Conditions
- Somatic Pain
- Being tested
- low-intensity focused ultrasound - low pressure, low-intensity focused ultrasound - medium pressure, low-intensity focused ultrasound - high pressure
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity focused ultrasound - low pressureDevice
low-intensity focused ultrasound applied to the S1.
low-intensity focused ultrasound - medium pressureDevice
low-intensity focused ultrasound applied to the S1.
low-intensity focused ultrasound - high pressureDevice
low-intensity focused ultrasound applied to the S1.
| Study group | Role | What they receive |
|---|---|---|
| Safety Check - high pressure application | Experimental | Small cohort to be collected prior to other study cohorts. Highest of 3 pressures of interest will be applied to the S1 (somatosensory cortex) with a follow-up MRI conducted 24-72 hours post. Receives: Device: low-intensity focused ultrasound - high pressure |
| EEG | Experimental | Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure). Receives: Device: low-intensity focused ultrasound - low pressure; Device: low-intensity focused ultrasound - medium pressure; Device: low-intensity focused ultrasound - high pressure |
| fMRI | Experimental | Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure). Receives: Device: low-intensity focused ultrasound - low pressure; Device: low-intensity focused ultrasound - medium pressure; Device: low-intensity focused ultrasound - high pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report of Symptoms Questionnaire
questionnaire of symptomology administered pre and post intervention.
Measured: pre/post intervention and 1 week post intervention.
MRI
pre and post structural MRI collection for cohort one - evaluated by Neuroradiologist for safety considerations. Primarily looking to rule out any evidence of bleeds.
Measured: pre and post intervention in cohort 1
Secondary outcomes (2)
EEG
Cohort 2 outcome measure is the EEG evoked potential response to the SEP stimulus pre and post LIFU application.
Measured: throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).
fMRI
Cohort 3 outcome measure is the functional MRI response to the SEP stimulus pre and post LIFU application. The somatosensory pathway will be of most interest in analysis of the BOLD response.
Measured: throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start16 Oct 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Why it stopped: Not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic PainStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs).
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynn Legon, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343883
- Sponsor's protocol ID
- 24-353
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Low-intensity Focused Ultrasound Pressure
- ClinicalTrials.gov ID
- NCT06343883
- Acronym / sponsor ID
- 24-353
- Conditions
- Somatic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not funded.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 3 Apr 2024 (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.
Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.
Detailed description
Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs).
| Arm | Type | Receives |
|---|---|---|
| Safety Check - high pressure application | Experimental | Device: low-intensity focused ultrasound - high pressureSmall cohort to be collected prior to other study cohorts. Highest of 3 pressures of interest will be applied to the S1 (somatosensory cortex) with a follow-up MRI conducted 24-72 hours post. |
| EEG | Experimental | Device: low-intensity focused ultrasound - low pressure, Device: low-intensity focused ultrasound - medium pressure, Device: low-intensity focused ultrasound - high pressureElectrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure). |
| fMRI | Experimental | Device: low-intensity focused ultrasound - low pressure, Device: low-intensity focused ultrasound - medium pressure, Device: low-intensity focused ultrasound - high pressureElectrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Understand and speak English
Key exclusion criteria (7 listed)
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
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 |
|---|---|---|
| low-intensity focused ultrasound - low pressurelow-intensity focused ultrasound applied to the S1. | Device | EEG, fMRI |
| low-intensity focused ultrasound - medium pressurelow-intensity focused ultrasound applied to the S1. | Device | EEG, fMRI |
| low-intensity focused ultrasound - high pressurelow-intensity focused ultrasound applied to the S1. | Device | EEG, Safety Check - high pressure application, fMRI |
Primary outcome
Report of Symptoms Questionnaire
Time frame: pre/post intervention and 1 week post intervention.
questionnaire of symptomology administered pre and post intervention.
MRI
Time frame: pre and post intervention in cohort 1
pre and post structural MRI collection for cohort one - evaluated by Neuroradiologist for safety considerations. Primarily looking to rule out any evidence of bleeds.
2 secondary outcomes
EEG
Time frame: throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).
fMRI
Time frame: throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).
Results and safety
The study was stopped early (reason given: Not funded.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity focused ultrasound - low pressure, low-intensity focused ultrasound - medium pressure and low-intensity focused ultrasound - high pressure in people with Somatic Pain, run by Virginia Polytechnic Institute and State University 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Aug 2026. 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?
The study was stopped early (reason given: Not funded.). Results are not available in the source record.
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?
Report of Symptoms Questionnaire (time frame: pre/post intervention and 1 week post intervention.). The study lists 2 primary outcomes in all. 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 4 Aug 2026.