Trigeminal NeuralgiaNCT07046247
Impact of Teflon Technique on Recurrence After Microvascular Decompression for Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia and Microvascular Decompression, run by University of Valencia at 1 site in Spain.
Trial summary
The study aims to see if shredded Teflon placed away from the trigeminal nerve is equally effective in pain control in Trigeminal Neuralgia while minimizing the risks of pain recurrence due to granuloma formation when this material is placed immediately close to the nerve in a pledget form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Microvascular Decompression, Teflon
- What is being tested?
- Microvascular decompression for trigeminal neuralgia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 12 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Trigeminal Neuralgia treated with microvascular decompression
Who may be able to join
- Trigeminal Neuralgia refractory to medical therapy and treated via microvascular decompression
Who cannot join
- Other craniofacial neuralgias, atypical facial pain, trigeminal neuralgia (TN) due to non-vascular causes (e.g., multiple sclerosis), and those with posterior fossa pathology, such as tumors, infarctions, hematomas, infections, or inflammatory lesions
- Patients treated by alternative methods, including percutaneous radiofrequency thermocoagulation, glycerol injection, balloon compression, or radiosurgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46015
About this study
Official title: Effect of Teflon Implant on Nerve Tissue and Its Relationship With Recurrences in the Treatment of Trigeminal Neuralgia by Microvascular Decompression, With Special Attention to the Method of Application: A Retrospective Clinical Study
The study aims to see if shredded Teflon placed away from the trigeminal nerve is equally effective in pain control in Trigeminal Neuralgia while minimizing the risks of pain recurrence due to granuloma formation when this material is placed immediately close to the nerve in a pledget form.
Read the detailed description
Complications associated with Teflon implants in the treatment of Trigeminal Neuralgia have been reported, including granuloma formation and persistent neuroinflammation, which can mimic tumor recurrence or lead to renewed symptoms. These concerns underscore the importance of precise implant positioning and accurate volume control. At the reporting institution, the investigators have consistently used a technique involving minimal amounts of shredded Teflon placed around the offending vessel, positioned at a distance from the trigeminal nerve itself. The goal of this technique is to elicit localized arachnoiditis to stabilize the artery and prevent re-compression. To date, no published studies have directly correlated the amount and form of Teflon used with subsequent inflammation and recurrence, particularly with imaging-based validation. The present study seeks to address this gap by retrospectively analyzing the outcomes of microvascular decompression procedures performed using this specific Teflon application method, correlating clinical outcomes with MRI findings to assess the degree of inflammatory response and the likelihood of symptom recurrence.
- Conditions
- Trigeminal Neuralgia, Microvascular Decompression, Teflon
- Being tested
- Microvascular decompression for trigeminal neuralgia
- Keywords
- Trigeminal Neuralgia, Microvascular Decompression, Teflon Implant, Neurosurgical Techniques, Postoperative Complications, Magnetic Resonance Imaging
- Medical subject headings
- Trigeminal Neuralgia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvascular decompression for trigeminal neuralgiaProcedure or surgery
Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant
| Study group | Role | What they receive |
|---|---|---|
| Teflon pledgets group | Is the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be Teflon, placed in the form of one or more pledgets between the nerve and the vessel. Receives: Procedure: Microvascular decompression for trigeminal neuralgia | |
| Shredded Teflon group | Is the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be shredded Teflon, placed around the displaced vessel away from the trigeminal nerve, aiming to induce a localized arachnoiditis away from the nerve that will fix the vessel in its new position, without any contact between the nerve and the vessel or the Teflon implant. Receives: Procedure: Microvascular decompression for trigeminal neuralgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ranking scale
The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)
Measured: 5 years
Barrow Neurological Institute Pain Intensity Scale
The Barrow Neurological Institute (BNI) Pain Intensity Scale will be used to assess pain control, ranging from 1 (no pain, no medication) to 5 (severe pain without relief)
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 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Vanaclocha, University of Valencia
- Investigators
- Teresa Moratal, Secretary, Study director, Fundación Consorcio Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046247
- Sponsor's protocol ID
- 188/2020
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the study is finised we will decide what to do
Publications
Sindou M, Leston J, Decullier E, Chapuis F. Microvascular decompression for primary trigeminal neuralgia: long-term effectiveness and prognostic factors in a series of 362 consecutive patients with clear-cut neurovascular conflicts who underwent pure decompression. J Neurosurg. 2007 Dec;107(6):1144-53. doi: 10.3171/JNS-07/12/1144.
PubMed 18077952Pressman E, Jha RT, Zavadskiy G, Kumar JI, van Loveren H, van Gompel JJ, Agazzi S. Teflon or Ivalon(R): a scoping review of implants used in microvascular decompression for trigeminal neuralgia. Neurosurg Rev. 2020 Feb;43(1):79-86. doi: 10.1007/s10143-019-01187-0. Epub 2019 Nov 30.
PubMed 31786660Capelle HH, Brandis A, Tschan CA, Krauss JK. Treatment of recurrent trigeminal neuralgia due to Teflon granuloma. J Headache Pain. 2010 Aug;11(4):339-44. doi: 10.1007/s10194-010-0213-4. Epub 2010 Apr 24.
PubMed 20419329Deep NL, Graffeo CS, Copeland WR 3rd, Link MJ, Atkinson JL, Neff BA, Raghunathan A, Carlson ML. Teflon granulomas mimicking cerebellopontine angle tumors following microvascular decompression. Laryngoscope. 2017 Mar;127(3):715-719. doi: 10.1002/lary.26126. Epub 2016 Jun 19.
PubMed 27320780Prasetya M, Adidharma P, Inoue T, Sulistyanto A, Fadhil, Oswari S, Keswani RR, Kusdiansah M, Aji YK, Arham A. Case report: Teflon granuloma following microvascular decompression manifesting as light-triggered trigeminal neuralgia. Front Surg. 2022 Jul 22;9:904434. doi: 10.3389/fsurg.2022.904434. eCollection 2022.
PubMed 36570809Sindou M, Leston JM, Decullier E, Chapuis F. Microvascular decompression for trigeminal neuralgia: the importance of a noncompressive technique--Kaplan-Meier analysis in a consecutive series of 330 patients. Neurosurgery. 2008 Oct;63(4 Suppl 2):341-50; discussion 350-1. doi: 10.1227/01.NEU.0000327022.79171.D6.
PubMed 18981841Zheng JH, Sun K, Zhang HT, Xie YJ, Wang-Yang LX, Chen HY, Wang C. A Study on the Recurrence Rate of Trigeminal Neuralgia after MVD and the Related Factors. J Neurol Surg B Skull Base. 2020 Oct;81(5):572-578. doi: 10.1055/s-0039-1692687. Epub 2019 Jul 24.
PubMed 33134025van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
PubMed 3363593Okon II, Menon SS, Osama M, Aiman M, Paleare LFF, Eliseo DL 3rd, Shafqat MD, Ezeaku CO, Ferreira MY, Razouqi Y, Kapsetaki M, Saniel JDR, Panit NM, Rao AG, Iqbal U, Otobo DD, Alkhawaldeh IM, Pereira FS, Akbar I, Kasimieh O, Chaurasia B. Microvascular decompression: a contemporary update. BMC Surg. 2025 Jan 11;25(1):20. doi: 10.1186/s12893-025-02762-7.
PubMed 39794712Amaya Pascasio L, De La Casa-Fages B, Esteban de Antonio E, Grandas F, Garcia-Leal R, Ruiz Juretschke F. Microvascular decompression for trigeminal neuralgia: A retrospective analysis of long-term outcomes and prognostic factors. Neurologia (Engl Ed). 2021 May 25:S0213-4853(21)00071-2. doi: 10.1016/j.nrl.2021.03.009. Online ahead of print. English, Spanish.
PubMed 34049739
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Teflon Implant on Nerve Tissue and Its Relationship With Recurrences in the Treatment of Trigeminal Neuralgia by Microvascular Decompression, With Special Attention to the Method of Application: A Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07046247
- Acronym / sponsor ID
- 188/2020
- Conditions
- Trigeminal Neuralgia, Microvascular Decompression, Teflon
- Keywords
- Trigeminal Neuralgia, Microvascular Decompression, Teflon Implant, Neurosurgical Techniques, Postoperative Complications, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 1 Jul 2025 (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.
The study aims to see if shredded Teflon placed away from the trigeminal nerve is equally effective in pain control in Trigeminal Neuralgia while minimizing the risks of pain recurrence due to granuloma formation when this material is placed immediately close to the nerve in a pledget form.
Detailed description
Complications associated with Teflon implants in the treatment of Trigeminal Neuralgia have been reported, including granuloma formation and persistent neuroinflammation, which can mimic tumor recurrence or lead to renewed symptoms. These concerns underscore the importance of precise implant positioning and accurate volume control. At the reporting institution, the investigators have consistently used a technique involving minimal amounts of shredded Teflon placed around the offending vessel, positioned at a distance from the trigeminal nerve itself. The goal of this technique is to elicit localized arachnoiditis to stabilize the artery and prevent re-compression. To date, no published studies have directly correlated the amount and form of Teflon used with subsequent inflammation and recurrence, particularly with imaging-based validation. The present study seeks to address this gap by retrospectively analyzing the outcomes of microvascular decompression procedures performed using this specific Teflon application method, correlating clinical outcomes with MRI findings to assess the degree of inflammatory response and the likelihood of symptom recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teflon pledgets group | – | Procedure: Microvascular decompression for trigeminal neuralgiaIs the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be Teflon, placed in the form of one or more pledgets between the nerve and the vessel. |
| Shredded Teflon group | – | Procedure: Microvascular decompression for trigeminal neuralgiaIs the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be shredded Teflon, placed around the displaced vessel away from the trigeminal nerve, aiming to induce a localized arachnoiditis away from the nerve that will fix the vessel in its new position, without any contact between the nerve and the vessel or the Teflon implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Trigeminal Neuralgia treated with microvascular decompression
Key inclusion criteria (1 listed)
- Trigeminal Neuralgia refractory to medical therapy and treated via microvascular decompression
Key exclusion criteria (2 listed)
- Other craniofacial neuralgias, atypical facial pain, trigeminal neuralgia (TN) due to non-vascular causes (e.g., multiple sclerosis), and those with posterior fossa pathology, such as tumors, infarctions, hematomas, infections, or inflammatory lesions
- Patients treated by alternative methods, including percutaneous radiofrequency thermocoagulation, glycerol injection, balloon compression, or radiosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microvascular decompression for trigeminal neuralgiaMicrovascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant | Procedure or surgery | Shredded Teflon group, Teflon pledgets group |
Primary outcome
Modified Ranking scale
Time frame: 5 years
The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)
Barrow Neurological Institute Pain Intensity Scale
Time frame: 5 years
The Barrow Neurological Institute (BNI) Pain Intensity Scale will be used to assess pain control, ranging from 1 (no pain, no medication) to 5 (severe pain without relief)
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 13 Feb 2026.
- Results publication: PubMed 18077952Sindou M, Leston J, Decullier E, Chapuis F. Microvascular decompression for primary trigeminal neuralgia: long-term effectiveness and prognostic factors in a series of 362 consecutive patients with clear-cut neurovascular conflicts who underwent pure decompression. J Neurosurg. 2007 Dec;107(6):1144-53. doi: 10.3171/JNS-07/12/1144.
- Results publication: PubMed 31786660Pressman E, Jha RT, Zavadskiy G, Kumar JI, van Loveren H, van Gompel JJ, Agazzi S. Teflon or Ivalon(R): a scoping review of implants used in microvascular decompression for trigeminal neuralgia. Neurosurg Rev. 2020 Feb;43(1):79-86. doi: 10.1007/s10143-019-01187-0. Epub 2019 Nov 30.
- Results publication: PubMed 20419329Capelle HH, Brandis A, Tschan CA, Krauss JK. Treatment of recurrent trigeminal neuralgia due to Teflon granuloma. J Headache Pain. 2010 Aug;11(4):339-44. doi: 10.1007/s10194-010-0213-4. Epub 2010 Apr 24.
- Results publication: PubMed 27320780Deep NL, Graffeo CS, Copeland WR 3rd, Link MJ, Atkinson JL, Neff BA, Raghunathan A, Carlson ML. Teflon granulomas mimicking cerebellopontine angle tumors following microvascular decompression. Laryngoscope. 2017 Mar;127(3):715-719. doi: 10.1002/lary.26126. Epub 2016 Jun 19.
- Results publication: PubMed 36570809Prasetya M, Adidharma P, Inoue T, Sulistyanto A, Fadhil, Oswari S, Keswani RR, Kusdiansah M, Aji YK, Arham A. Case report: Teflon granuloma following microvascular decompression manifesting as light-triggered trigeminal neuralgia. Front Surg. 2022 Jul 22;9:904434. doi: 10.3389/fsurg.2022.904434. eCollection 2022.
- Results publication: PubMed 18981841Sindou M, Leston JM, Decullier E, Chapuis F. Microvascular decompression for trigeminal neuralgia: the importance of a noncompressive technique--Kaplan-Meier analysis in a consecutive series of 330 patients. Neurosurgery. 2008 Oct;63(4 Suppl 2):341-50; discussion 350-1. doi: 10.1227/01.NEU.0000327022.79171.D6.
- Results publication: PubMed 33134025Zheng JH, Sun K, Zhang HT, Xie YJ, Wang-Yang LX, Chen HY, Wang C. A Study on the Recurrence Rate of Trigeminal Neuralgia after MVD and the Related Factors. J Neurol Surg B Skull Base. 2020 Oct;81(5):572-578. doi: 10.1055/s-0039-1692687. Epub 2019 Jul 24.
- Results publication: PubMed 3363593van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
- Results publication: PubMed 39794712Okon II, Menon SS, Osama M, Aiman M, Paleare LFF, Eliseo DL 3rd, Shafqat MD, Ezeaku CO, Ferreira MY, Razouqi Y, Kapsetaki M, Saniel JDR, Panit NM, Rao AG, Iqbal U, Otobo DD, Alkhawaldeh IM, Pereira FS, Akbar I, Kasimieh O, Chaurasia B. Microvascular decompression: a contemporary update. BMC Surg. 2025 Jan 11;25(1):20. doi: 10.1186/s12893-025-02762-7.
- Results publication: PubMed 34049739Amaya Pascasio L, De La Casa-Fages B, Esteban de Antonio E, Grandas F, Garcia-Leal R, Ruiz Juretschke F. Microvascular decompression for trigeminal neuralgia: A retrospective analysis of long-term outcomes and prognostic factors. Neurologia (Engl Ed). 2021 May 25:S0213-4853(21)00071-2. doi: 10.1016/j.nrl.2021.03.009. Online ahead of print. English, Spanish.
- Individual participant dataSharing planned: Undecided. Once the study is finised we will decide what to do
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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.
Teresa Moratal, Secretary study director
Fundación Consorcio Hospital General Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia and Microvascular Decompression, run by University of Valencia at 1 site in Spain.
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 1 inclusion and 2 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Modified Ranking scale (time frame: 5 years). 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 NCT07046247, which also lists 10 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 13 Feb 2026.