Noninvasive Brain Stimulation for Pain Relief

Pain, Acute Clinical Trial

Official title:

Noninvasive Brain Stimulation for Pain Relief

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283643
• Other study ID #: 21311
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 149
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Pain, Acute
• Pain, Chronic
• Pain, Experimental

Intervention

Other:
• Transcranial Focused Ultrasound
Non-invasive brain stimulation technique
• Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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