Investigation of Low-intensity Focused Ultrasound Pressure

Somatic Pain Clinical Trial

Official title:

Investigation of Low-intensity Focused Ultrasound Pressure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343883
• Other study ID #: 24-353
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Jessica Florig, MPH
• Phone: 540-526-2261
• Email: jnw[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Understand and speak English

Exclusion Criteria:

1. Claustrophobia (scanning environment may be uncomfortable).

2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

3. Contraindications to CT: pregnancy

4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)

5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)

6. History of head injury resulting in loss of consciousness for >10 minutes.

7. History of alcohol or drug dependence (through self-report).

Related Conditions & MeSH terms

• Nociceptive Pain
• Somatic Pain

Intervention

Device:
• low-intensity focused ultrasound - low pressure
low-intensity focused ultrasound applied to the S1.
• low-intensity focused ultrasound - medium pressure
low-intensity focused ultrasound applied to the S1.
• low-intensity focused ultrasound - high pressure
low-intensity focused ultrasound applied to the S1.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Report of Symptoms Questionnaire	questionnaire of symptomology administered pre and post intervention.	pre/post intervention and 1 week post intervention.
Primary	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.	pre and post intervention in cohort 1
Secondary	EEG	Cohort 2 outcome measure is the EEG evoked potential response to the SEP stimulus pre and post LIFU application.	throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).
Secondary	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.	throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).