Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04864964 |
| Other study ID # |
Ehab-Hossam trigeminal |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2014 |
| Est. completion date |
July 15, 2020 |
Study information
| Verified date |
November 2021 |
| Source |
National Cancer Institute, Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Interventional therapies for Trigeminal Neuralgia are of variable efficacy and safety, and
have different results for different periods of time before the recurrence of symptoms.
Interventional therapy for TN is either destructive with trigeminal nerve sensory function
destroyed intentionally or non-destructive with decompression of the trigeminal nerve and
preservation of its regular function. The most common procedures in treating TN pain are the
use of radiofrequency (RF). the aim of this study is to assess the possible value of motor
index as a prediction of success of radiofrequency lesioning of the Gasserian ganglion during
treatment of trigeminal neuralgia.
Description:
Trigeminal neuralgia (TN) is defined by the International Headache Society (IHS) as
"unilateral disorder characterized by brief electric shock-like pains, abrupt in onset and
termination, and limited to the distribution of one or more divisions of the trigeminal
nerve". It is considered the worst type of facial pain and described as intense, sharp,
stabbing, and shooting like electric shock pain. It can be triggered by touch, chewing,
laughing, shaving or face wash .
The IHS suggests a classification of TN as either classic (essential or idiopathic) TN (CTN)
or symptomatic TN (STN; pain indistinguishable from that of CTN, but caused by a demonstrable
structural lesion other than vascular compression).Treatment of TN is conservative, surgical
or interventional. Pharmacotherapy with carbamazepine is tried early in cases of TN but has
many side effects .Other medications can be used in the treatment of TN, include
oxycarbazepine, gabapentin, pregabalin, baclofen, valproate, clonazepam, phenytoin, and
lamotrigime .
The most clinically appropriate treatment includes surgical microvascular decompression
(MVD), stereotactic radiation therapy, gamma knife (SGK), percutaneous balloon decompression,
percutaneous glycerol rhizolysis, percutaneous radiofrequency (RF) of the Gasserian ganglion
(GG), and GG stimulation and neuromodulation. Interventional therapies for TN are of variable
efficacy and safety, and have different results for different periods of time before the
recurrence of symptoms. Interventional therapy for TN is either destructive with trigeminal
nerve sensory function destroyed intentionally or non-destructive with decompression of the
trigeminalnerve and preservation of its regular function. The most common procedures in
treating TN pain are the use of radiofrequency (RF) .
Radiofrequency thermos-coagulation of the GG is thought to selectively destroy the pain
fibers by thermos-coagulation at > 65°C , that helps reduce pain and prevent triggering, but
can cause bothersome dysesthesia. Another method, pulsed radiofrequency (PRF) which defined
as the delivery of short pulses of RF via a needle tip, thereby a short exposure at the same
temperature will result in less thermal tissue destruction (6).
Combined conventional and pulsed radiofrequency (CCPRF) achieved comparable pain relief to
PRF treatment alone in patients with chronic pain, the combination of PRF and CRF would
increase the effect of CRF and reduce the need for long-duration CRF (LCRF) and its attendant
side effects .
The main objective of this study is to assess the possible value of motor index as a
prediction of success of radiofrequency lesioning of the Gasserian ganglion during treatment
of trigeminal neuralgia.
