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Clinical Trials/NCT04283643
NCT04283643
Unknown
N/A

Noninvasive Brain Stimulation for Pain Relief

University of Virginia1 site in 1 country149 target enrollmentApril 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
University of Virginia
Enrollment
149
Locations
1
Primary Endpoint
Numeric Pain Rating Scale
Last Updated
6 years ago

Overview

Brief Summary

Non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial focused ultrasound (FUS), is be applied to healthy human subjects, acute pain patients, and chronic pain patients to investigate their uses for pain relief.

Detailed Description

The research team will be using non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial focused ultrasound (FUS) to investigate their uses for pain relief in humans: healthy human subjects, acute pain patients, and chronic pain patients. Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) recordings will be collected to achieve the following objectives: Objective 1 aims to determine the effects of noninvasive brain stimulation on the pain-related brain activities during pain processing. We hypothesize that noninvasive brain stimulation approaches will increase or decrease cortical activity upon processing painful input. Objective 2 aims to determine the effects of noninvasive brain stimulation on pain intensity and/or pain-related behavioral assessments. We hypothesize that noninvasive brain stimulation will influence pain-intensity and/or pain-related behavioral assessments. Objective 3 aims to investigate the correlation between brain activity and pain relief after noninvasive brain stimulation. We hypothesize that noninvasive brain stimulation will suppress cortical activity in pain-related brain areas, reduce pain intensity, and/or improve pain-related behavioral assessments.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
April 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy adults between 18 and 80 years of age.
  • Chronic and Acute pain patients: must have an MRI (for ultrasound targeting)

Exclusion Criteria

  • Direct report to the study team member
  • History of brain surgery
  • History of seizure
  • Have alcohol consumption exceeding 50 drinks/month
  • Have history of opioid abuse (all subjects), or any recent opioid use (healthy controls)
  • Have implant like pacemaker and aneurysm clip
  • Current of psychiatric disease such as anxiety or depression, which is not optimally treated
  • Current infection
  • Current wound on the skin of upper and lower extremities
  • Chronic pain patients: current chronic pain is not optimal controlled by pain medications (i.e. Pain VAS \>5)

Outcomes

Primary Outcomes

Numeric Pain Rating Scale

Time Frame: immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline

Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale

Study Sites (1)

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