Noninvasive Brain Stimulation for Pain Relief

Study Overview
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Brief Summary
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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
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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.

Official Title
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Noninvasive Brain Stimulation for Pain Relief

Conditions
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Pain, Acute, Pain, Chronic, Pain, Experimental

Intervention / Treatment
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* Other: Transcranial Focused Ultrasound
* Other: Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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 Pregnant 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Within subjects design of real and control stimulation, pain measures and behavioral assessments may be compared between healthy subjects and pain groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Human Subjects<br>Healthy human subjects will complete study procedures in the research lab at UVA. They will complete pain-related behavioral questionnaires and undergo experimental pain testing for temperature and laser stimuli for real and control conditions of brain stimulation. | Other: Transcranial Focused Ultrasound<br>* Non-invasive brain stimulation technique<br>Other: Transcranial Magnetic Stimulation<br>* Non-invasive brain stimulation technique<br>|
| Experimental: Acute Pain Patients<br>Acute Pain Patients will complete study procedures in the hospital or clinic at UVA. They will complete pain-related behavioral questionnaires and undergo experimental pain testing for temperature and laser stimuli for real and control conditions of brain stimulation, as well as rate their ongoing pain. | Other: Transcranial Focused Ultrasound<br>* Non-invasive brain stimulation technique<br>Other: Transcranial Magnetic Stimulation<br>* Non-invasive brain stimulation technique<br>|
| Experimental: Chronic Pain Patients<br>Chronic Pain Patients will complete study procedures in the hospital or clinic at UVA. They will complete pain-related behavioral questionnaires and undergo experimental pain testing for temperature and laser stimuli for real and control conditions of brain stimulation, as well as rate their ongoing pain. | Other: Transcranial Focused Ultrasound<br>* Non-invasive brain stimulation technique<br>Other: Transcranial Magnetic Stimulation<br>* Non-invasive brain stimulation technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale | immediately after brain stimulation (same day, approximately 5-10 minutes after baseline) as compared to baseline | 
| Numeric Pain Rating Scale | Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale | immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Focused Ultrasound, Noninvasive Neuromodulation