Noninvasive Brain Stimulation for Pain Relief

University of Virginia

Status: Unknown

Conditions: Pain, Experimental; Pain, Acute; Pain, Chronic

Treatments: Other: Transcranial Focused Ultrasound; Other: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04283643

21311

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

149 participants in 3 patient groups

Healthy Human Subjects

Experimental group

Description:

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.

Treatment:

Other: Transcranial Magnetic Stimulation

Other: Transcranial Focused Ultrasound

Acute Pain Patients

Experimental group

Description:

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.

Treatment:

Other: Transcranial Magnetic Stimulation

Other: Transcranial Focused Ultrasound

Chronic Pain Patients

Experimental group

Description:

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.

Treatment:

Other: Transcranial Magnetic Stimulation

Other: Transcranial Focused Ultrasound