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Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-intensity focused ultrasound - low pressure | Device | low-intensity focused ultrasound applied to the S1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Report of Symptoms Questionnaire | questionnaire of symptomology administered pre and post intervention. | 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. | pre and post intervention in cohort 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| fMRI |
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Inclusion Criteria:
Understand and speak English
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
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No masking, no sham. All subjects will receive all conditions, all of which are active.
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| low-intensity focused ultrasound - medium pressure | Device | low-intensity focused ultrasound applied to the S1. |
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| low-intensity focused ultrasound - high pressure | Device | low-intensity focused ultrasound applied to the S1. |
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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). |