Noninvasive Brain Stimulation for Pain Relief

NCT04283643 | Unknown

• 1 other identifier: 21311
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Pain, Chronic; Pain, Experimental

Keywords

Transcranial Magnetic Stimulation; Focused Ultrasound; Noninvasive Neuromodulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Healthy Human Subjects

EXPERIMENTAL

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; Other: Transcranial Magnetic Stimulation

Acute Pain Patients

EXPERIMENTAL

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; Other: Transcranial Magnetic Stimulation

Chronic Pain Patients

EXPERIMENTAL

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; Other: Transcranial Magnetic Stimulation

Interventions

Transcranial Focused Ultrasound OTHER

Non-invasive brain stimulation technique

Acute Pain Patients; Chronic Pain Patients; Healthy Human Subjects

Transcranial Magnetic Stimulation OTHER

Non-invasive brain stimulation technique

Acute Pain Patients; Chronic Pain Patients; Healthy Human Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults between 18 and 80 years of age.
• Chronic and Acute pain patients: must have an MRI (for ultrasound targeting)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within subjects design of real and control stimulation, pain measures and behavioral assessments may be compared between healthy subjects and pain groups.

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 25, 2020
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)