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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04241562
Ethics application status
Date submitted
22/01/2020
Date registered
27/01/2020

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified, individual participant data will be made available immediately following publication via an open-access data repository.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04241562