Applications of Realtime Functional Magnetic Resonance Im... | NCT01111617

Studies
Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )

NCT01111617

Sponsor

Stanford University

Status

Completed

Last Update Posted

Mar 25, 2024Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Real-time fMRI feedback

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
95194

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Nov 2023Actual

Completion Date

Nov 2023Actual

First Submitted Date

Jan 29, 2010

First Submission Date that Met QC Criteria

Apr 26, 2010

First Posted Date

Apr 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2024

Last Update Posted Date

Mar 25, 2024Actual

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real-Time fMRI	Experimental	Real-Time fMRI	Procedure: Real-time fMRI feedback

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Real-time fMRI feedback	Procedure	Patients receive real-time fMRI biofeedback to modulate pain	Real-Time fMRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain reduction as measured by visual analog scale (VAS) pain report		Within the 2 hour feedback session

Secondary Outcomes

Measure	Description	Time Frame
Control of brain activity as measured by fMRI analysis		Within the 2 hour feedback session

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65
Chronic Pain patient or healthy control
Ability to perform the experimental task

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sean Mackey	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided