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Noninvasive Brain Stimulation for Pain Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283643
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Acute Pain, Chronic Pain, Experimental Other: Transcranial Focused Ultrasound Other: Transcranial Magnetic Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Noninvasive Brain Stimulation for Pain Relief
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

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




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283643


Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sarah Adams    434-243-4319    neuromodlab@hscmail.mcc.virginia.edu   
Principal Investigator: Chang-Chia Liu, PhD         
Sponsors and Collaborators
University of Virginia
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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT04283643    
Other Study ID Numbers: 21311
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Virginia:
Transcranial Magnetic Stimulation
Focused Ultrasound
Noninvasive Neuromodulation
Additional relevant MeSH terms:
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Acute Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms