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Trial registered on ANZCTR


Registration number
ACTRN12624001272583
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Cellular Pathophysiology of Trigeminal Neuropathic Pain
Scientific title
Identifying the cellular pathophysiology of chronic trigeminal neuropathic pain in diagnosed patients
Secondary ID [1] 312910 0
None
Universal Trial Number (UTN)
Trial acronym
CPTNP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic Pain 335070 0
Condition category
Condition code
Neurological 331578 331578 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnetic resonance imaging (MRI) of brain function on one occasion for 60 minutes delivered by a trained radiographer who is employed by the scanning facility.

Positron emission tomography (PET) of radio tracer binding indicating astrocytic and glial activity in Orofacial Neuropathic Pain patients. Two PET sessions, 90 minutes each, separated by a minimum of two weeks between each session. PET radio ligand is administered by a qualified clinical nurse and the images will be collected by a qualified research technologist.

Location: both MRI and PET are located in the same facility/centre (Melbourne Brain Imaging Unit) - 30 Royal Parade, Parkville Victoria 3010

As this study only involves two sessions, with all procedures occurring within the Melbourne Brain Centre Imaging Unit over the course of roughly 2.5 hours each session, adherence to the protocols solely requires regular monitoring of participants throughout the study, which is maintained via regular check ins inside both the MRI and PET scanner environments through digital speakers. The radiographer and technologist in charge of collection of these datasets respectively, alongside the researcher involved in the study will, between scans and at regular intervals check in with participants and monitor quality of data collected (to avoid artefacts such as movement, etc.).

All procedures involving the radioligand are conducted by the qualified clinical nurse on staff at the scanning facility, who will both make the injection and monitor participants immediately following this process. Primary concerns are extravasation or fainting from needle-phobia. Both these adverse/serious adverse events are controlled for in processes disclosed in the study protocol, however in regards to fidelity, participants will be monitored for appropriate uptake of radiotracer to ensure image quality will be of a standard useable to produce research outputs. Inside the MRI scanner, as above, both the researcher and radiographer will monitor data quality to ensure no artefact of motion or similar is present in recorded images.
Intervention code [1] 329445 0
Early detection / Screening
Comparator / control treatment
This study involves two groups, Pain-free controls and those with diagnosed trigeminal neuropathic pain. The "control treatment" is the same experimental procedures / imaging paradigms being conducted on the control group as in TNP patients for comparison of brain imaging data
Control group
Active

Outcomes
Primary outcome [1] 339313 0
Astrocytic Involvement in Neuropathic Pain
Timepoint [1] 339313 0
Baseline measurement at participant screening measured once during MRI and PET scans.
Secondary outcome [1] 439436 0
Functional activation
Timepoint [1] 439436 0
Baseline measurement at participant screening measured once during MRI and PET scans.
Secondary outcome [2] 440516 0
Radiotracer binding potential
Timepoint [2] 440516 0
Baseline measurement at participant screening measured once during MRI and PET scans.
Secondary outcome [3] 440767 0
General anxiety disorder 7 (GAD7)
Timepoint [3] 440767 0
Baseline measurement at participant screening measured once during MRI and PET scans.
Secondary outcome [4] 440768 0
The state trait anxiety
Timepoint [4] 440768 0
Baseline measurement at participant screening measured once during MRI and PET scans.
Secondary outcome [5] 440769 0
The BECKS depression inventory
Timepoint [5] 440769 0
Baseline measurement at participant screening measured once during MRI and PET scans.
Secondary outcome [6] 440770 0
Pain catastrophising questionnaire
Timepoint [6] 440770 0
Baseline measurement at participant screening measured once during MRI and PET scans.

Eligibility
Key inclusion criteria
Patient group: positive diagnosis of trigeminal neuropathic pain.
Control group: no present or diagnosed pain lasting longer than 3 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient group: current pregnancy, MRI contraindications. no positive diagnosis of trigeminal neuropathic pain.
Control group: current pregnancy, MRI contraindications. any pain lasting longer than 3 months.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/11/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317342 0
Government body
Name [1] 317342 0
NHMRC
Country [1] 317342 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319627 0
None
Name [1] 319627 0
Address [1] 319627 0
Country [1] 319627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316073 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 316073 0
Ethics committee country [1] 316073 0
Australia
Date submitted for ethics approval [1] 316073 0
17/03/2024
Approval date [1] 316073 0
20/08/2024
Ethics approval number [1] 316073 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136690 0
Prof Luke Henderson
Address 136690 0
University of Sydney, 94 Mallett Street Mallett Street, Camperdown 2050 NSW
Country 136690 0
Australia
Phone 136690 0
+61 437024976
Fax 136690 0
Email 136690 0
luke.henderson@sydney.edu.au
Contact person for public queries
Name 136691 0
Luke Henderson
Address 136691 0
University of Sydney, 94 Mallett Street Mallett Street, Camperdown 2050 NSW
Country 136691 0
Australia
Phone 136691 0
+61 437024976
Fax 136691 0
Email 136691 0
luke.henderson@sydney.edu.au
Contact person for scientific queries
Name 136692 0
Luke Henderson
Address 136692 0
University of Sydney, 94 Mallett Street Mallett Street, Camperdown 2050 NSW
Country 136692 0
Australia
Phone 136692 0
+61 437024976
Fax 136692 0
Email 136692 0
luke.henderson@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24164Ethical approval    388408-(Uploaded-05-09-2024-14-10-25)-Decision notification letter (1).pdf
24165Informed consent form    388408-(Uploaded-05-09-2024-14-10-25)-5b. Consent form v4 clean.docx
24166Statistical analysis plan    388408-(Uploaded-05-09-2024-14-10-25)-STATISTICAL METHODS.docx
24167Study protocol    388408-(Uploaded-05-09-2024-14-10-25)-2. Protocol.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.