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Noninvasive Brain Stimulation for Pain Relief

Primary Purpose

Pain, Acute, Pain, Chronic, Pain, Experimental

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Focused Ultrasound
Transcranial Magnetic Stimulation
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Acute focused on measuring Transcranial Magnetic Stimulation, Focused Ultrasound, Noninvasive Neuromodulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy Human Subjects

Acute Pain Patients

Chronic Pain Patients

Arm 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.

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 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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
Numeric Pain Rating Scale
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale

Secondary Outcome Measures

Full Information

First Posted
February 3, 2020
Last Updated
February 21, 2020
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04283643
Brief Title
Noninvasive Brain Stimulation for Pain Relief
Official Title
Noninvasive Brain Stimulation for Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chronic, Pain, Experimental
Keywords
Transcranial Magnetic Stimulation, Focused Ultrasound, Noninvasive Neuromodulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
149 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Human Subjects
Arm Type
Experimental
Arm 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.
Arm Title
Acute Pain Patients
Arm Type
Experimental
Arm 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.
Arm Title
Chronic Pain Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Transcranial Focused Ultrasound
Intervention Description
Non-invasive brain stimulation technique
Intervention Type
Other
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Non-invasive brain stimulation technique
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
Time Frame
immediately after brain stimulation (same day, approximately 5-10 minutes after baseline) as compared to baseline
Title
Numeric Pain Rating Scale
Description
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
Time Frame
immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Adams
Phone
434-243-4319
Email
neuromodlab@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Chang-Chia Liu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Noninvasive Brain Stimulation for Pain Relief

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