Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Manohar Sharma

ORCID ID

Contact details

The Walton Centre for Neurology and Neurosurgery
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes