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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).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03185442
Enrollment
25
Registered
2017-06-14
Start date
2018-07-02
Completion date
2019-12-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Lumbar Radiculopathy

Keywords

fMRI, PRF

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.

Detailed description

Detect and prove the central effects of PRF and show the objective working mechanism. PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism. The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.

Interventions

DEVICEPulsed Radiofrequency

Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 18-75 y * Radicular pain in lumbar region more than 6 weeks, neuropathic

Exclusion criteria

* Coagulopathy * Implanted PM or SCS device * Pregnancy * Unwilling to undergo MRI * Psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
Central working mechanism6 weeksfMRI-BOLD

Secondary

MeasureTime frameDescription
Central working mechanism3 times in 6 weeksNumeric Rating Scale (NRS)

Countries

Belgium

Contacts

Primary ContactVeerle Van Mossevelde, Data Nurse
veerle.vanmossevelde@uzbrussel.be+3224763134
Backup ContactDirk De Clippeleir, Data Nurse
dirk.declippeleir@uzbrussel.be+324763580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026