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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04241562




Registration number
NCT04241562
Ethics application status
Date submitted
22/01/2020
Date registered
27/01/2020
Date last updated
4/04/2023

Titles & IDs
Public title
Validation of a Novel Cortical Biomarker Signature for Pain
Scientific title
Validation of a Novel Cortical Biomarker Signature for Pain
Secondary ID [1] 0 0
1R61NS113269-01
Universal Trial Number (UTN)
Trial acronym
PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
TMD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Injection of Nerve Growth Factor

Other interventions: Injection of Nerve Growth Factor
Injection of Nerve Growth Factor to the right masseter
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak pain intensity from diary ratings
Timepoint [1] 0 0
0 to 30 days following NGF injection
Secondary outcome [1] 0 0
Average Peak daily pain intensity from from diary ratings
Timepoint [1] 0 0
0 to 30 days following NGF injection
Secondary outcome [2] 0 0
The time between pain onset and complete resolution of pain for two consecutive days
Timepoint [2] 0 0
0 to 30 days following NGF injection

Eligibility
Key inclusion criteria
- healthy
Minimum age
18 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2022
Sample size
Target
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Maryland, Baltimore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Neuroscience Research Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04241562
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Seminowicz, PhD
Address 0 0
University of Maryland School of Dentistry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04241562