Noninvasive Brain Stimulation for Pain Relief

NCT ID: NCT04283643

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-04-01

Brief Summary

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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

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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.

Conditions

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Pain, Acute Pain, Chronic Pain, Experimental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Within subjects design of real and control stimulation, pain measures and behavioral assessments may be compared between healthy subjects and pain groups.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type OTHER

Non-invasive brain stimulation technique

Transcranial Magnetic Stimulation

Intervention Type OTHER

Non-invasive brain stimulation technique

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.

Group Type EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type OTHER

Non-invasive brain stimulation technique

Transcranial Magnetic Stimulation

Intervention Type OTHER

Non-invasive brain stimulation technique

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.

Group Type EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type OTHER

Non-invasive brain stimulation technique

Transcranial Magnetic Stimulation

Intervention Type OTHER

Non-invasive brain stimulation technique

Interventions

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Transcranial Focused Ultrasound

Non-invasive brain stimulation technique

Intervention Type OTHER

Transcranial Magnetic Stimulation

Non-invasive brain stimulation technique

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Sarah Adams

Role: primary

434-243-4319

Other Identifiers

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21311

Identifier Type: -

Identifier Source: org_study_id

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