Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.

April 16, 2019 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Jette, Vlaams Brabant, Belgium, 1090
        • Recruiting
        • Pain Clinic Universitair Ziekenhuis Brussel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivier Decoster, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF-fMRI
Device: Pulsed Radiofrequency
Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central working mechanism
Time Frame: 6 weeks
fMRI-BOLD
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central working mechanism
Time Frame: 3 times in 6 weeks
Numeric Rating Scale (NRS)
3 times in 6 weeks
Central working mechanism
Time Frame: 2 times in 6 weeks
Douleur Neuropathique Questionnaire 4 (DN 4)
2 times in 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Anticipated)

July 15, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fMRI-PRF-DRG v 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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