Validation of a Novel Cortical Biomarker Signature for Pain | NCT04241562

Studies
Validation of a Novel Cortical Biomarker Signature for Pain

NCT04241562

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Apr 4, 2023Actual

Enrollment

159Actual

Phase

Not provided

Conditions

Interventions

Injection of Nerve Growth Factor

Countries

United States
Australia

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

Apr 2023

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

Nov 4, 2020Actual

Primary Completion Date

Oct 10, 2022Actual

Completion Date

Oct 10, 2022Actual

First Submitted Date

Jan 22, 2020

First Submission Date that Met QC Criteria

Jan 22, 2020

First Posted Date

Jan 27, 2020Actual

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

Apr 3, 2023

Last Update Posted Date

Apr 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Seminowicz, Associate Professor, University of Maryland, BaltimorePrincipal Investigator

Lead Sponsor

University of Maryland, BaltimoreOTHER

Collaborators

Name	Class
Neuroscience Research Australia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The study aims to undertake analytical validation of an brain biomarker in healthy participants experiencing a model of sustained temporomandibular pain. The biomarker could detect participants at greater risk of developing more severe pain.

Detailed Description

Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The investigative team has uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). The biomarker signature combines resting state sensorimotor peak alpha frequency (PAF) measured using electroencephalograph (EEG) and corticomotor excitability (CME) measured using transcranial magnetic stimulation (TMS). This PAF/CME biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). In the current study, the investigators aim to undertake analytical validation of this biomarker in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain (masseter intramuscular injection of nerve growth factor). The investigators will record PAF/CME at multiple time points before and during the development of pain and use online diaries and in-laboratory assessments of pain, sleep, stress, and other psychosocial variables. Specifically, the investigators will test if the biomarker signature predicts an individual's pain sensitivity (high- or low-pain sensitive).

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

159Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection of Nerve Growth Factor	Other	Injection of Nerve Growth Factor to the right masseter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak pain intensity from diary ratings	Pain sensitivity	0 to 30 days following NGF injection

Secondary Outcomes

Measure	Description	Time Frame
Average Peak daily pain intensity from from diary ratings	Pain severity	0 to 30 days following NGF injection
The time between pain onset and complete resolution of pain for two consecutive days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy

Exclusion Criteria:

unable or refusal to provide written consent
presence of any acute pain disorder
history or presence of any chronic pain disorder
history or presence of any other medical or psychiatric compliant
use of opioids or illicit drugs in the past 3 months
pregnant or lactating women
excessive alcohol use
contraindicated for TMS (metal implants, epilepsy)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Healthy men and women with no medical complaints, no history of chronic pain and no current acute pain between the ages of 18 and 44 years will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David A Seminowicz, PhD	University of Maryland School of Dentistry	Principal Investigator
Siobhan M Schabrun, PhD	Neuroscience Research Australia; University of New South Wales	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland School of Dentistry		Baltimore	Maryland	21201	United States
Neuroscience Research Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32766469	Derived	Seminowicz DA, Bilska K, Chowdhury NS, Skippen P, Millard SK, Chiang AKI, Chen S, Furman AJ, Schabrun SM. A novel cortical biomarker signature for predicting pain sensitivity: protocol for the PREDICT longitudinal analytical validation study. Pain Rep. 2020 Jul 27;5(4):e833. doi: 10.1097/PR9.0000000000000833. eCollection 2020 Jul-Aug.