Noninvasive Brain Stimulation for Pain Relief

February 21, 2020 updated by: University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Chang-Chia Liu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy Human Subjects
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
Non-invasive brain stimulation technique
Other: Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique
EXPERIMENTAL: Acute Pain Patients
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
Non-invasive brain stimulation technique
Other: Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique
EXPERIMENTAL: Chronic Pain Patients
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
Non-invasive brain stimulation technique
Other: Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: immediately after brain stimulation (same day, approximately 5-10 minutes after baseline) as compared to baseline
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
Time Frame: 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
immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (ACTUAL)

February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Acute

Clinical Trials on Transcranial Focused Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe