Clinical trial NCT04283643: Noninvasive Brain Stimulation for Pain Relief
Official title: Noninvasive Brain Stimulation for Pain Relief
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Pain, Chronic
Pain, Experimental
Keywords: Transcranial Magnetic Stimulation
Focused Ultrasound
Noninvasive Neuromodulation
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within subjects design of real and control stimulation, pain measures and behavioral assessments may be compared between healthy subjects and pain groups.
Primary purpose: BASIC_SCIENCE

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.

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
* 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)

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: immediately after brain stimulation (same day, approximately 5-10 minutes after baseline) as compared to baseline
measure: Numeric Pain Rating Scale
timeFrame: immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: