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Status unknownNCT04283643Updated Feb 25, 2020

Noninvasive Brain Stimulation for Pain Relief

An interventional study of Transcranial Focused Ultrasound and Transcranial Magnetic Stimulation in Pain, Acute, Pain, Chronic and Pain, Experimental, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by University of Virginia · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Apr 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Acute
  • Pain, Chronic
  • Pain, Experimental

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Keywords

  • Transcranial Magnetic Stimulation
  • Focused Ultrasound
  • Noninvasive Neuromodulation
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 149 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
149 participants (estimated)

Study 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.

    Other: Transcranial Focused Ultrasound · Other: Transcranial Magnetic 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.

    Other: Transcranial Focused Ultrasound · Other: Transcranial Magnetic Stimulation

  • 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 · Other: Transcranial Magnetic Stimulation

Interventions

  • OtherTranscranial Focused Ultrasound

    Non-invasive brain stimulation technique

  • OtherTranscranial Magnetic Stimulation

    Non-invasive brain stimulation technique

06

What researchers measure

Primary outcomes

  1. Numeric Pain Rating Scale

    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

  2. Numeric Pain Rating Scale

    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

07

Study locations

1 of 1 sites recruiting
  • University of Virginia
    Charlottesville, Virginia 22903, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04283643
Lead sponsor
University of Virginia
Responsible party
Sponsor
First posted
Feb 25, 2020
Start date
Apr 1, 2019
Primary completion
Apr 1, 2021 (estimated)
Completion
Apr 1, 2021 (estimated)
Last update
Feb 25, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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