N/A
N=29
Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain
Healthy Adults
Bottom Line
View on ClinicalTrials.gov: NCT04339972 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Quantitative Sensory Threshold Temperature Levels (Degrees Celsius) — .51; 1.08 Degrees Celsius
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LIFUP (Device); Sham LIFUP (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Sensory Threshold Temperature Levels (Degrees Celsius) |
.51; 1.08 | — |
| PRIMARY Number of Participants With Significant Functional MRI Blood Oxygen Level Dependent (BOLD) Signal Changes |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18-45 years of age
- Healthy volunteer
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04339972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.