Pain, AcuteNCT04283643
Noninvasive Brain Stimulation for Pain Relief
A study testing Transcranial Focused Ultrasound and Transcranial Magnetic Stimulation in people with Pain, Acute and Pain, Chronic, run by University of Virginia at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Pain, Chronic, Pain, Experimental
- What is being tested?
- Transcranial Focused Ultrasound and Transcranial Magnetic Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults between 18 and 80 years of age.
- Chronic and Acute pain patients: must have an MRI (for ultrasound targeting)
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Sarah Adams, 434-243-4319, neuromodlab@hscmail.mcc.virginia.edu
Chang-Chia Liu, PhD
About this study
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.
- Conditions
- Pain, Acute, Pain, Chronic, Pain, Experimental
- Being tested
- Transcranial Focused Ultrasound, Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, Focused Ultrasound, Noninvasive Neuromodulation
- Medical subject headings
- Acute Pain, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Focused UltrasoundOther
Non-invasive brain stimulation technique
Transcranial Magnetic StimulationOther
Non-invasive brain stimulation technique
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Transcranial Focused Ultrasound; Other: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
Measured: 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
Measured: immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283643
- Sponsor's protocol ID
- 21311
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Brain Stimulation for Pain Relief
- ClinicalTrials.gov ID
- NCT04283643
- Acronym / sponsor ID
- 21311
- Conditions
- Pain, Acute, Pain, Chronic, Pain, Experimental
- Keywords
- Transcranial Magnetic Stimulation, Focused Ultrasound, Noninvasive Neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Within subjects design of real and control stimulation, pain measures and behavioral assessments may be compared between healthy subjects and pain groups.
| Arm | Type | Receives |
|---|---|---|
| Healthy Human Subjects | Experimental | Other: Transcranial Focused Ultrasound, Other: Transcranial Magnetic StimulationHealthy 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 | Experimental | Other: Transcranial Focused Ultrasound, Other: Transcranial Magnetic StimulationAcute 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 | Experimental | Other: Transcranial Focused Ultrasound, Other: Transcranial Magnetic StimulationChronic 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults between 18 and 80 years of age.
- Chronic and Acute pain patients: must have an MRI (for ultrasound targeting)
Key exclusion criteria (11 listed)
- Direct report to the study team member
- History of brain surgery
- History of seizure
- Pregnant
- Have alcohol consumption exceeding 50 drinks/month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Focused UltrasoundNon-invasive brain stimulation technique | Other | Acute Pain Patients, Chronic Pain Patients, Healthy Human Subjects |
| Transcranial Magnetic StimulationNon-invasive brain stimulation technique | Other | Acute Pain Patients, Chronic Pain Patients, Healthy Human Subjects |
Primary outcome
Numeric Pain Rating Scale
Time frame: immediately after brain stimulation (same day, approximately 5-10 minutes after baseline) as compared to baseline
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
Numeric Pain Rating Scale
Time frame: immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Virginia
Charlottesville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Focused Ultrasound and Transcranial Magnetic Stimulation in people with Pain, Acute and Pain, Chronic, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.