Autonomic DysfunctionNCT05834829
Low-intensity Focused Ultrasound and Autonomic Response
A study testing Low-intensity focused ultrasound neuromodulation in people with Autonomic Dysfunction, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Dysfunction
- What is being tested?
- Low-intensity focused ultrasound neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Does not meet exclusion criteria.
Who cannot join
- The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.
- 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 central nervous system (CNS) effects (e.g. Alzheimer's) -
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
Show all 11Show fewer
- History of head injury resulting in loss of consciousness for >10 minutes.
- History of alcohol or drug dependence (through self-report).
- History of cardiac disease
- A current or prior use of any cardiac medication (e.g. beta blockers or other anti-arrhythmics)
- A history of diabetes mellitus or use of diabetic medications (e.g. metformin).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Investigation of Low-intensity Focused Ultrasound to the Salience Network on Autonomic Function
Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.
Read the detailed description
Characterize the effect of LIFU to the bilateral dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC)) on autonomic control. The dPI is a critical brain area involved in autonomic function, being a core recipient of ascending pain and autonomic function. Similarly, the dACC has been strongly implicated in autonomic control and works with the insula for autonomic processing. Inconveniently, these brain regions lie deep to the cortex, prohibiting access using conventional noninvasive methods like transcranial magnetic stimulation (TMS). LIFU can be focused at depth to reach the insula and ACC with high spatial precision. However, the effect of LIFU to the human dPI and dACC on autonomic control is unknown. To address this, the investigators will target the right dPI and the dACC to assess how LIFU to each of these areas affects autonomic responses and subjective report to the cold pressor task, a safe, reproducible autonomic challenge.
- Conditions
- Autonomic Dysfunction
- Being tested
- Low-intensity focused ultrasound neuromodulation, Sham Low-intensity focused ultrasound
- Medical subject headings
- Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity focused ultrasound neuromodulationDevice
ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.
Sham Low-intensity focused ultrasoundDevice
sham application of ultrasound using blocking of the ultrasound waves of the transducer.
| Study group | Role | What they receive |
|---|---|---|
| dPI | Experimental | LIFU to the dPI Receives: Device: Low-intensity focused ultrasound neuromodulation |
| ACC | Experimental | LIFU to the ACC Receives: Device: Low-intensity focused ultrasound neuromodulation |
| Sham | Sham comparator | Sham LIFU application Receives: Device: Sham Low-intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic tone response - Heart Rate Variability (HRV)
Changes in HRV
Measured: through study completion, an average of 1 month
Sympathetic tone response - Heart Rate (HR)
Changes in HR
Measured: through study completion, an average of 1 month
Sympathetic tone response - Blood Pressure (BP)
Changes in BP (systolic and diastolic pressure)
Measured: through study completion, an average of 1 month
Sympathetic tone response - Electrodermal Response (EDR)
Changes in EDR
Measured: through study completion, an average of 1 month
Sympathetic tone response - Electroencephalography (EEG)
Changes in low and high frequency power
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start22 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysfunctionStudies 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
- Crossover
- Model description
- three arm model, participants receive each intervention/sham (dPI, ACC, or Sham) one per study visit in a randomized order.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
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
- NCT05834829
- Sponsor's protocol ID
- 23-049
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2023
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Low-intensity Focused Ultrasound to the Salience Network on Autonomic Function
- ClinicalTrials.gov ID
- NCT05834829
- Acronym / sponsor ID
- 23-049
- Conditions
- Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Apr 2023 (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.
Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.
Detailed description
Characterize the effect of LIFU to the bilateral dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC)) on autonomic control. The dPI is a critical brain area involved in autonomic function, being a core recipient of ascending pain and autonomic function. Similarly, the dACC has been strongly implicated in autonomic control and works with the insula for autonomic processing. Inconveniently, these brain regions lie deep to the cortex, prohibiting access using conventional noninvasive methods like transcranial magnetic stimulation (TMS). LIFU can be focused at depth to reach the insula and ACC with high spatial precision. However, the effect of LIFU to the human dPI and dACC on autonomic control is unknown. To address this, the investigators will target the right dPI and the dACC to assess how LIFU to each of these areas affects autonomic responses and subjective report to the cold pressor task, a safe, reproducible autonomic challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three arm model, participants receive each intervention/sham (dPI, ACC, or Sham) one per study visit in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| dPI | Experimental | Device: Low-intensity focused ultrasound neuromodulationLIFU to the dPI |
| ACC | Experimental | Device: Low-intensity focused ultrasound neuromodulationLIFU to the ACC |
| Sham | Sham comparator | Device: Sham Low-intensity focused ultrasoundSham LIFU application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Does not meet exclusion criteria.
Key exclusion criteria (11 listed)
- The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.
- 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 central nervous system (CNS) effects (e.g. Alzheimer's) -
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 neuromodulationultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation. | Device | ACC, dPI |
| Sham Low-intensity focused ultrasoundsham application of ultrasound using blocking of the ultrasound waves of the transducer. | Device | Sham |
Primary outcome
Sympathetic tone response - Heart Rate Variability (HRV)
Time frame: through study completion, an average of 1 month
Changes in HRV
Sympathetic tone response - Heart Rate (HR)
Time frame: through study completion, an average of 1 month
Changes in HR
Sympathetic tone response - Blood Pressure (BP)
Time frame: through study completion, an average of 1 month
Changes in BP (systolic and diastolic pressure)
Sympathetic tone response - Electrodermal Response (EDR)
Time frame: through study completion, an average of 1 month
Changes in EDR
Sympathetic tone response - Electroencephalography (EEG)
Time frame: through study completion, an average of 1 month
Changes in low and high frequency power
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.
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 neuromodulation in people with Autonomic Dysfunction, 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 11 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sympathetic tone response - Heart Rate Variability (HRV) (time frame: through study completion, an average of 1 month). The study lists 5 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 8 Jun 2026.