Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.
Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).
1 other identifier
interventional
25
1 country
1
Brief Summary
Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 17, 2019
April 1, 2019
1 year
May 22, 2017
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Central working mechanism
fMRI-BOLD
6 weeks
Secondary Outcomes (2)
Central working mechanism
3 times in 6 weeks
Central working mechanism
2 times in 6 weeks
Study Arms (1)
PRF-fMRI
EXPERIMENTALInterventions
Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses
Eligibility Criteria
You may qualify if:
- Radicular pain in lumbar region more than 6 weeks, neuropathic
You may not qualify if:
- Coagulopathy
- Implanted PM or SCS device
- Pregnancy
- Unwilling to undergo MRI
- Psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain Clinic Universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier De Coster, MD
Universitair Ziekenhuis Brussel
- STUDY DIRECTOR
Patrice Forget, PhD MD
Universitair Ziekenhuis Brussel
- STUDY CHAIR
Jan Poelaert, PhDMD
Universitair Ziekenhuis Brussel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 22, 2017
First Posted
June 14, 2017
Study Start
July 2, 2018
Primary Completion
July 15, 2019
Study Completion
December 31, 2019
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share