Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain

NCT04339972 | Completed Results FDA Device

• 1 other identifier: Pro00082376
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Quantitative Sensory Threshold Temperature Levels (Degrees Celsius)

  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.

  Change from Baseline 45 minutes after LIFUP in the scanner

• Number of Participants With Significant Functional MRI Blood Oxygen Level Dependent (BOLD) Signal Changes

  Blood oxygenation level dependent (BOLD) imaging is the standard technique used to generate images in functional MRI (fMRI) studies, and relies on regional differences in cerebral blood flow to delineate regional activity. We will measure the brain's BOLD signal as a response to thermal stimulus within the MRI scanner and determine whether a significant (p ≤ 0.005 uncorrected) increase or decrease in BOLD signal intensity is indicated as a result of either Active or Sham LIFUP.

  Changes within 3 seconds after receiving LIFUP

Study Arms (2)

Active LIFUP then Sham LIFUP

EXPERIMENTAL

Real LIFUP is delivered to the participant for visit 1, followed by sham lifup visit 2

Device: LIFUP

Sham LIFUP then Active LIFUP

SHAM COMPARATOR

Sham LIFUP is delivered to the participant for visit 1, followed by real lifup visit 2

Device: Sham LIFUP

Interventions

LIFUP DEVICE

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.

Active LIFUP then Sham LIFUP

Sham LIFUP DEVICE

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

Sham LIFUP then Active LIFUP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Healthy volunteer

You may not qualify if:

• seizure history (individual or family)
• history of depression
• hospitalizations or surgeries in the previous 6 months
• currently experiencing pain
• history of chronic pain
• metal implants or objects (e.g. pacemakers, metal plates, wires)
• pregnant
• alcohol dependence
• illicit drug use in the previous 6 months
• known allergy to capsaicin
• history of brain surgery or brain lesions
• history of loss of consciousness (greater than 15 min)
• on stimulants or medications that lower seizure threshold.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Dr. Mark George or Dr. Bashar Badran
• Organization: Medical University of South Carolina

georgem@musc.edu

843-792-6076

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 9, 2020
• Study Start: February 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2021
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-07

Locations

US (1)