PainNCT01111617
Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )
A study testing Real-time fMRI feedback in people with Pain, run by Stanford University at 1 site in United States.
Trial summary
The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Real-time fMRI feedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Chronic Pain patient or healthy control
- Ability to perform the experimental task
Who cannot join
- MRI contraindication (metal implants, claustrophobia, pregnant or planning to become pregnant)
- History of psychiatric disorder (at the discretion of the investigator as to whether it interferes with the experimental task)
- History of Blistering
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Applications of Realtime fMRI Phase II
The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain.
Read the detailed description
A research study that looks at pain and how you experience pain. This research project aims to use virtual reality-based real-time functional Magnetic Resonance Imaging (rtfMRI) to assess brain activation during the experience of pain and while subjects attempt to mentally control their pain response.
- Conditions
- Pain
- Being tested
- Real-time fMRI feedback
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI feedbackProcedure or surgery
Patients receive real-time fMRI biofeedback to modulate pain
| Study group | Role | What they receive |
|---|---|---|
| Real-Time fMRI | Experimental | Real-Time fMRI Receives: Procedure: Real-time fMRI feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction as measured by visual analog scale (VAS) pain report
Measured: Within the 2 hour feedback session
Secondary outcomes (1)
Control of brain activity as measured by fMRI analysis
Measured: Within the 2 hour feedback session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startJan 2014
- Primary completionNov 2023
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mackey, Stanford University
- Investigators
- Sean Mackey, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111617
- Sponsor's protocol ID
- SU-11062007-809
- Other IDs
- 95194
- Status last verified
- Mar 2024
- First submitted
- 29 Jan 2010
- Last updated
- 25 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of Realtime fMRI Phase II
- ClinicalTrials.gov ID
- NCT01111617
- Acronym / sponsor ID
- SU-11062007-809
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 27 Apr 2010 (estimated)
- 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.
The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain.
Detailed description
A research study that looks at pain and how you experience pain. This research project aims to use virtual reality-based real-time functional Magnetic Resonance Imaging (rtfMRI) to assess brain activation during the experience of pain and while subjects attempt to mentally control their pain response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-Time fMRI | Experimental | Procedure: Real-time fMRI feedbackReal-Time fMRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65
- Chronic Pain patient or healthy control
- Ability to perform the experimental task
Key exclusion criteria (3 listed)
- MRI contraindication (metal implants, claustrophobia, pregnant or planning to become pregnant)
- History of psychiatric disorder (at the discretion of the investigator as to whether it interferes with the experimental task)
- History of Blistering
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 |
|---|---|---|
| Real-time fMRI feedbackPatients receive real-time fMRI biofeedback to modulate pain | Procedure or surgery | Real-Time fMRI |
Primary outcome
Pain reduction as measured by visual analog scale (VAS) pain report
Time frame: Within the 2 hour feedback session
1 secondary outcome
Control of brain activity as measured by fMRI analysis
Time frame: Within the 2 hour feedback session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Sean Mackey principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time fMRI feedback in people with Pain, run by Stanford University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 25 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction as measured by visual analog scale (VAS) pain report (time frame: Within the 2 hour feedback session). 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 Mar 2024.