Somatic Pain
Conditions
Brief summary
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.
Interventions
DEVICElow-intensity focused ultrasound - low pressure
low-intensity focused ultrasound applied to the S1.
DEVICElow-intensity focused ultrasound - medium pressure
low-intensity focused ultrasound applied to the S1.
DEVICElow-intensity focused ultrasound - high pressure
low-intensity focused ultrasound applied to the S1.
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
No masking, no sham. All subjects will receive all conditions, all of which are active.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report of Symptoms Questionnaire | pre/post intervention and 1 week post intervention. | questionnaire of symptomology administered pre and post intervention. |
| MRI | 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
| Measure | Time frame | Description |
|---|---|---|
| EEG | 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. |
| fMRI | 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. |
Countries
United States
Outcome results
None listed