Recruiting

Noninvasive Brain Stimulation

Sponsor:

University of Virginia

Code:

NCT04283643

Conditions

Pain, Acute

Pain, Chronic

Pain, Experimental

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Transcranial Focused Ultrasound

Transcranial Magnetic Stimulation

Study Details

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

Study ID

NCT04283643

Start date

Apr 1, 2019

Status verified date

Feb, 2020

Completion date

Apr 1, 2021

Anticipated

Primary completion date

Apr 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

149 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Transcranial Focused Ultrasound

Non-invasive brain stimulation technique

Transcranial Magnetic Stimulation

Non-invasive brain stimulation technique

Primary outcome measure

  • Numeric Pain Rating Scale [ Time Frame: 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 ]

Central Contacts and Locations

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.virginia.edu

Principal Investigator:

Chang-Chia Liu, PhD

More Information

Sponsor

University of Virginia

Last update posted

Feb 25, 2020

Last verified

Feb, 2020

Keywords

  • Transcranial Magnetic Stimulation
  • Focused Ultrasound
  • Noninvasive Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2020-02-25.