Noninvasive Brain Stimulation for Pain Relief

Not Applicable

• Conditions: Pain, Acute; Pain, Experimental; Pain, Chronic
• Interventions: Other: Transcranial Focused Ultrasound; Other: Transcranial Magnetic Stimulation

• Registration Number: NCT04283643
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-25
• Last Update Posted: 2020-02-25
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 149

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Human Subjects	Transcranial Focused Ultrasound	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.
Healthy Human Subjects	Transcranial Magnetic Stimulation	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.
Acute Pain Patients	Transcranial Magnetic Stimulation	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.
Chronic Pain Patients	Transcranial Magnetic Stimulation	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.
Acute Pain Patients	Transcranial Focused Ultrasound	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.
Chronic Pain Patients	Transcranial Focused Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	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

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States