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Enrolling by Invitation

NCT Number: NCT06343883

Investigation of Low-intensity Focused Ultrasound Pressure

Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.

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Key information

Conditions

Somatic Pain Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Understand and speak English

Exclusion criteria

  • 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).

Treatment and study plan

low-intensity focused ultrasound - low pressure

Device

low-intensity focused ultrasound applied to the S1.

low-intensity focused ultrasound - medium pressure

Device

low-intensity focused ultrasound applied to the S1.

low-intensity focused ultrasound - high pressure

Device

low-intensity focused ultrasound applied to the S1.

Primary outcomes

  1. Report of Symptoms Questionnaire

    Time frame: pre/post intervention and 1 week post intervention.

    questionnaire of symptomology administered pre and post intervention.

  2. 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.

Secondary outcomes

  1. EEG

    Time frame: throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).

    Cohort 2 outcome measure is the EEG evoked potential response to the SEP stimulus pre and post LIFU application.

  2. fMRI

    Time frame: throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).

    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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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