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NCT04339972 · ClinicalTrials.gov registry record · NA
Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain
A NA study of Healthy Adults, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT04339972: Completed NA study of Healthy Adults, sponsored by Medical University of South Carolina.
NCT04339972 is a NA study of Healthy Adults that has completed, run by Medical University of South Carolina. The registered enrollment target is 29 participants, below the 86-participant average among 33 other Healthy Adults trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04339972, a NA study of Healthy Adults, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The anterior nuclei of the thalamus in addition to periaqueductal gray (PAG) and rostral ventromedial medulla (RVM) are integral regions of a supraspinal opioidergic structure that regulate pain perception. With the capability to influence deep neurological tissues, low intensity frequency ultrasound pulsation (LIFUP) can likely modulate this circuit and induce analgesia. LIFUP deep brain modulation is achieved by induction of focused mechanical waveforms that traverse the cranium and underlying brain tissue. The low frequency of the ultrasonic wave consequently alters neuronal transmission and causes action potential variations through mechanical means, rather than thermal. The purpose of this study is to examine whether stimulation of the anterior nuclei of the thalamus via LIFUP induces analgesia. We hypothesize that suppression of the anterior nuclei of the thalamus will induce a temporary increase in pain tolerance. Moreover, the behavioral changes in pain will correlate with specific regional BOLD changes during pain.
Primary Outcome
Quantitative Sensory Testing (QST) is a valuable method for diagnosing peripheral nervous system disorders, including pain. This outcome quantifies the level of thermal stimulus temperature (degrees celsius) required for a participant to feel pain on their wrist. The temperatures will be recorded before and after LIFUP.
Conditions Studied
Interventions
- DEVICE LIFUP
- DEVICE Sham LIFUP
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2021-07-01 |
| Phase | NA |
What the finished NCT04339972 record still lists
NCT04339972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 86-participant average among 33 other Healthy Adults trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Healthy Adults appearing as the primary indexed condition, and to 2 interventions - of which LIFUP is the first listed.
NCT04339972 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04339972 about?
NCT04339972 is a clinical study titled "Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain". The anterior nuclei of the thalamus in addition to periaqueductal gray (PAG) and rostral ventromedial medulla (RVM) are integral regions of a supraspinal opioidergic structure that regulate pain perception. With the capability to influence deep neurological tissues, low intensity frequency ultrasoun...
What is the current status of trial NCT04339972?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2019-02-01. Estimated completion is 2021-07-01.
What conditions does trial NCT04339972 study?
This clinical trial studies the following conditions: Healthy Adults.
What interventions are being tested in trial NCT04339972?
The interventions under investigation include: LIFUP (DEVICE), Sham LIFUP (DEVICE).
Who is sponsoring clinical trial NCT04339972?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04339972 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04339972's enrollment target sits among peer trials
29 24th of 33 higher than 10 of 33 other Healthy Adults trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Adults trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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