Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0259149058
Study information
Scientific title
Acronym
Study hypothesis
Does Pulsed Radio frequency (RF) lesioning produce any neurological damage? Standard RF lesioning produces a lesion by electronically heating the tip of the electrode to a controllable temperature between 60 and 90 degrees C to deliberately partially damage the nerve tissue, thus reducing the pain. Pulsed RF is claimed to be an effective way of producing an analgesic effect without damaging the nerve in any way, because the average temperature at the tip of the electrode is 42 degrees. It is claimed that it affects function in an unexplained way, without any neurological damage. Nerve damage can produce numbness with pain persisting, or a further neuropathic pain developing as a result of the nerve damage.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nervous System Diseases: Neuralgia
Intervention
Parallel group, patient and assessor blind randomised controlled study. Patients would be checked as to their suitability for the study according to the entry criteria, and then receive a full assessment. Suitable patients would be investigated with an MRTA and a MRI of brain, together with laboratory investigation, neurophysiology and QST. Patients would be stratified as to typical or atypical forms of TGN, and randomised to receive either standard or pulsed RF lesion to the Gasserian Ganglion. Both patients and assessors would be blinded as to the treatment performed. The blinding would be maintained until return of pain, at which time a standard RF lesion or other clinically acceptable treatment such as balloon compression, stereotactic radiosurgery etc. will be performed. The pulsed or conventional RF lesion will be performed using the Radionics lesion generator. The patient will receive Midazolam sedation in the standard way. The RF needle (RDG Neurotherm cannula) will be positioned in the foramem ovale under X-ray control and the appropriate trigeminal root located with sensory thresholds of less than 0.5v29. A pain diary will be kept, using a pain logger, for the week preceding the RF lesion, together with a diary of interference with activities of daily living. This diary would continue after the procedure for 1 month, and will be re-introduced if pain relief follows the procedure and pain then returns at a later date. Time to return of pain will be noted. The patient will have specific instructions to notify the researchers when pain returns, and will be re-assessed at that time. Formal assessment will be done otherwise at 1-2 week(s), 1 month, 3 months, 6 months, 9 months and 12 months, 18 months and 2 years.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2004
Overall trial end date
01/05/2008
Reason abandoned
Lack of time from trialist. Poor patient recruitment.
Eligibility
Participant inclusion criteria
Patients will be selected who have a diagnosis of trigeminal neuralgia with unilateral pain, failure of acceptable pharmacological control, failure of mirovascular decompression, or patients not otherwise suitable for surgery.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2004
Recruitment end date
01/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre for Neurology and Neurosurgery
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary