CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
LIFUP +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04339972
NCT04339972N/ACompleted

Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain

Medical University of South Carolina·interventional·Posted Apr 9, 2020·Updated Aug 19, 2021

In Brief

A clinical study evaluating LIFUP and Sham LIFUP for Healthy Adults. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adults
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 9, 2020
Enrollment StartFeb 1, 2019
Primary CompletionJul 1, 2020
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.2 years ago

Interventions

LIFUPdevice

Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision.

Sham LIFUPdevice

The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound.