Decoding Chronic Pain With fMRI | NCT01766973

Studies
Decoding Chronic Pain With fMRI

NCT01766973

Sponsor

University of Cambridge

Status

Completed

Last Update Posted

Jun 8, 2018Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Chronic Back Pain

Interventions

Not provided

Countries

United Kingdom

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

Status Module

Record Verification Date

Jun 2018

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

Apr 6, 2013Actual

Primary Completion Date

Apr 6, 2016Actual

Completion Date

Jun 6, 2018Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

Jan 10, 2013

First Posted Date

Jan 11, 2013Estimated

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

Jun 6, 2018

Last Update Posted Date

Jun 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Ben Seymour, Wellcome Intermediate Clinical Fellow, University of CambridgePrincipal Investigator

Lead Sponsor

University of CambridgeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recent evidence suggests that chronic pain is associated with abnormal connectivity between brain regions associated with the processing of pain. We aim to test the diagnostic power of resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic back pain. Using new methods of image acquisition and analysis we aim to develop a computational method to correctly classify patients and matched control subjects.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic back pain		Adults, >6months duration
Control		Age and sex matched controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional brain connectivity	Assessed by fMRI	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-60
pain > 6months
right-handed
non-smoking
mechanical back pain

Exclusion Criteria:

significant neurological or psychiatric disease
major systemic illness
MRI exclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Adults with >6 months of mechanical lower back pain, not sue to any major systemic disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben Seymour, MRCP PhD	University of Cambridge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addenbrookes Hospital		Cambridge		CB2 0QQ	United Kingdom