Trigeminal Neuralgia, IdiopathicNCT05101577
Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation
An observational study of Trigeminal Neuralgia, Idiopathic, run by Shifa Clinical Research Center.
Trial summary
This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Read more about this study
- Who is it for?
- Ages 27 to 91 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia, Idiopathic
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 91 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients of all genders presenting to Pain Clinic, referred of otherwise, diagnosed to have trigeminal neuralgia without concomitant central nervous pathologies including space occupying lesions, vascular and auto-immune disorders, who were planned for stereotactic rhizotomy under deep sedation and monitored anesthesia care as daycare cases.
Who may be able to join
- 1. Patients fulfilling ICHD criteria:
- Recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria B and C
- Pain has all of the following characteristics:
- lasting from a fraction of a second to 2 minutes
- severe intensity
- electric shock-like, shooting, stabbing or sharp in quality B. Precipitated by innocuous stimuli within the affected trigeminal distribution C. Not better accounted for by another ICHD-3 diagnosis.
- 2. Age: Adults of both sexes 3. MRI brain ruled out organic or structural pathologies
Who cannot join
- 1. Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.
- 2. Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.
- 3. Patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure 4. Patients on oral anticoagulants 5. Patients declared high risk or ASA 3 and above for general anaesthesia.
About this study
Official title: Recurrence Rate of Trigeminal Neuralgia in Patients Treated With Percutaneous Stereotactic Continuous Radiofrequency Rhizotomy at 80 Degrees Celsius for 90 Seconds- a Single Center Study.
This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.
- Conditions
- Trigeminal Neuralgia, Idiopathic
- Keywords
- trigeminal neuralgia, stereotactic rhizotomy, radiofrequency ablation, recurrence
- Medical subject headings
- Trigeminal Neuralgia, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy
Recurrence of pain in the same distribution of the trigeminal nerve branch or branches for which the stereotactic rhizotomy was originally performed
Measured: Recurrence within 12 months of the intervention
Proportion of patients with neurological deficits after stereotactic rhizotomy
locally deviced protocol for stereotactic rhizotomy of the involved trigeminal gangion dictates the use of higher temperature of 80 degree Celsius for 90 seconds, which translates into better pain relief and longer pain free intervals at the cost of higher percentage of sensory and motor deficits
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Sep 2016
- Primary completion31 Aug 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trigeminal Neuralgia, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hasan Wasim, Shifa Clinical Research Center
- Investigators
- Salman A. Saleem, MBBS;FCPS, Study director, Shifa Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101577
- Sponsor's protocol ID
- ShifaCRC
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taha JM, Tew JM Jr, Buncher CR. A prospective 15-year follow up of 154 consecutive patients with trigeminal neuralgia treated by percutaneous stereotactic radiofrequency thermal rhizotomy. J Neurosurg. 1995 Dec;83(6):989-93. doi: 10.3171/jns.1995.83.6.0989.
PubMed 7490643Rashid A, Pintea B, Kinfe TM, Surber G, Hamm K, Bostrom JP. LINAC stereotactic radiosurgery for trigeminal neuralgia -retrospective two-institutional examination of treatment outcomes. Radiat Oncol. 2018 Aug 22;13(1):153. doi: 10.1186/s13014-018-1102-2.
PubMed 30134992Kao CH, Lee MH, Yang JT, Tsai YH, Lin MH. Percutaneous Radiofrequency Rhizotomy Is Equally Effective for Trigeminal Neuralgia Patients with or Without Neurovascular Compression. Pain Med. 2022 Apr 8;23(4):807-814. doi: 10.1093/pm/pnab221.
PubMed 34264315Zhao G, Sun X, Zhang Z, Yang H, Zheng X, Feng B. Clinical efficacy of MVD combined with PSR in the treatment of primary trigeminal neuralgia. Exp Ther Med. 2020 Aug;20(2):1582-1588. doi: 10.3892/etm.2020.8871. Epub 2020 Jun 10.
PubMed 32742390Elnashar A, Patel SK, Kurbanov A, Zvereva K, Keller JT, Grande AW. Comprehensive anatomy of the foramen ovale critical to percutaneous stereotactic radiofrequency rhizotomy: cadaveric study of dry skulls. J Neurosurg. 2019 Apr 19;132(5):1414-1422. doi: 10.3171/2019.1.JNS18899. Print 2020 May 1.
PubMed 31003215
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate of Trigeminal Neuralgia in Patients Treated With Percutaneous Stereotactic Continuous Radiofrequency Rhizotomy at 80 Degrees Celsius for 90 Seconds- a Single Center Study.
- ClinicalTrials.gov ID
- NCT05101577
- Acronym / sponsor ID
- ShifaCRC
- Conditions
- Trigeminal Neuralgia, Idiopathic
- Keywords
- trigeminal neuralgia, stereotactic rhizotomy, radiofrequency ablation, recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shifa Clinical Research CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 27 to 91 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of all genders presenting to Pain Clinic, referred of otherwise, diagnosed to have trigeminal neuralgia without concomitant central nervous pathologies including space occupying lesions, vascular and auto-immune disorders, who were planned for stereotactic rhizotomy under deep sedation and monitored anesthesia care as daycare cases.
Key inclusion criteria (7 listed)
- 1. Patients fulfilling ICHD criteria:
- Recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria B and C
- Pain has all of the following characteristics:
- lasting from a fraction of a second to 2 minutes
- severe intensity
Key exclusion criteria (3 listed)
- 1. Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.
- 2. Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.
- 3. Patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure 4. Patients on oral anticoagulants 5. Patients declared high risk or ASA 3 and above for general anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy
Time frame: Recurrence within 12 months of the intervention
Recurrence of pain in the same distribution of the trigeminal nerve branch or branches for which the stereotactic rhizotomy was originally performed
Proportion of patients with neurological deficits after stereotactic rhizotomy
Time frame: 5 years
locally deviced protocol for stereotactic rhizotomy of the involved trigeminal gangion dictates the use of higher temperature of 80 degree Celsius for 90 seconds, which translates into better pain relief and longer pain free intervals at the cost of higher percentage of sensory and motor deficits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 7490643Taha JM, Tew JM Jr, Buncher CR. A prospective 15-year follow up of 154 consecutive patients with trigeminal neuralgia treated by percutaneous stereotactic radiofrequency thermal rhizotomy. J Neurosurg. 1995 Dec;83(6):989-93. doi: 10.3171/jns.1995.83.6.0989.
- Background: PubMed 30134992Rashid A, Pintea B, Kinfe TM, Surber G, Hamm K, Bostrom JP. LINAC stereotactic radiosurgery for trigeminal neuralgia -retrospective two-institutional examination of treatment outcomes. Radiat Oncol. 2018 Aug 22;13(1):153. doi: 10.1186/s13014-018-1102-2.
- Background: PubMed 34264315Kao CH, Lee MH, Yang JT, Tsai YH, Lin MH. Percutaneous Radiofrequency Rhizotomy Is Equally Effective for Trigeminal Neuralgia Patients with or Without Neurovascular Compression. Pain Med. 2022 Apr 8;23(4):807-814. doi: 10.1093/pm/pnab221.
- Background: PubMed 32742390Zhao G, Sun X, Zhang Z, Yang H, Zheng X, Feng B. Clinical efficacy of MVD combined with PSR in the treatment of primary trigeminal neuralgia. Exp Ther Med. 2020 Aug;20(2):1582-1588. doi: 10.3892/etm.2020.8871. Epub 2020 Jun 10.
- Background: PubMed 31003215Elnashar A, Patel SK, Kurbanov A, Zvereva K, Keller JT, Grande AW. Comprehensive anatomy of the foramen ovale critical to percutaneous stereotactic radiofrequency rhizotomy: cadaveric study of dry skulls. J Neurosurg. 2019 Apr 19;132(5):1414-1422. doi: 10.3171/2019.1.JNS18899. Print 2020 May 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salman A. Saleem, MBBS;FCPS study director
Shifa Clinical Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, Idiopathic, run by Shifa Clinical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy (time frame: Recurrence within 12 months of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05101577, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.