Trigeminal NeuralgiaNCT06278194
Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment
A study testing Gasserian Ganglion Radiofrequency Thermocoagulation in people with Trigeminal Neuralgia and Gasserian Ganglion; Lesion, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Trigeminal Neuralgia, Gasserian Ganglion; Lesion
- What is being tested?
- Gasserian Ganglion Radiofrequency Thermocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain refractory to medical therapy for at least 3 months
- Planning radiofrequency thermocoagulation of gasserian ganglion
- Accept ultrasound measurements to be performed
Who cannot join
- Refused to participate in the study
- Not attending follow-ups regularly
- Coagulation disorder
- Pregnancy
- Localized or systemic infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir
Burak Erken, Medical Doctor, +0902129096000, burak_erken@hotmail.com
Tuba Tanyel Saraçoğlu, MD, tuba.saracoglu1@saglik.gov.tr
About this study
Official title: Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment
Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.
The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.
In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.
- Conditions
- Trigeminal Neuralgia, Gasserian Ganglion; Lesion
- Being tested
- Gasserian Ganglion Radiofrequency Thermocoagulation
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gasserian Ganglion Radiofrequency ThermocoagulationProcedure or surgery
Gasserian ganglion radiofrequency thermocoagulation is performed in the operating room under fluoroscopy. In sterile condition, the foramen ovale is shown by the pain management specialist under fluoroscopy guidance. After this condition, the entry of the needle is marked and anaesthetised with local anaesthetic. After the entry of the gasserian ganglion with the radiofrequency needle, 10 cm long, the location is checked with sensory and motor stimulation. If the placement is correct, 70 degrees 70 seconds of radiofrequency thermocoagulation is applied.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with gasserian ganglion RFT for trigeminal neuralgia | Other | In patients who have undergone radiofrequency thermocoagulation (RFT) of the gasserian ganglion for the treatment of trigeminal neuralgia, the thickness of the masseter muscle will be measured bilaterally, free and contracted, by ultrasound on the day of the procedure (just before the procedure) and at 1 and 3 months after the procedure. Receives: Procedure: Gasserian Ganglion Radiofrequency Thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Measured: Pre-procedural time
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Measured: Post-procedural first month
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Measured: Post-procedural third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start15 Mar 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Erken, Başakşehir Çam & Sakura City Hospital
- Investigators
- Tuba Tanyel Saraçoğlu, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278194
- Sponsor's protocol ID
- 22.11.2023.589
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment
- ClinicalTrials.gov ID
- NCT06278194
- Acronym / sponsor ID
- 22.11.2023.589
- Conditions
- Trigeminal Neuralgia, Gasserian Ganglion; Lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 26 Feb 2024 (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.
Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.
The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.
In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with gasserian ganglion RFT for trigeminal neuralgia | Other | Procedure: Gasserian Ganglion Radiofrequency ThermocoagulationIn patients who have undergone radiofrequency thermocoagulation (RFT) of the gasserian ganglion for the treatment of trigeminal neuralgia, the thickness of the masseter muscle will be measured bilaterally, free and contracted, by ultrasound on the day of the procedure (just before the procedure) and at 1 and 3 months after the procedure. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain refractory to medical therapy for at least 3 months
- Planning radiofrequency thermocoagulation of gasserian ganglion
- Accept ultrasound measurements to be performed
Key exclusion criteria (5 listed)
- Refused to participate in the study
- Not attending follow-ups regularly
- Coagulation disorder
- Pregnancy
- Localized or systemic infection
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 |
|---|---|---|
| Gasserian Ganglion Radiofrequency ThermocoagulationGasserian ganglion radiofrequency thermocoagulation is performed in the operating room under fluoroscopy. In sterile condition, the foramen ovale is shown by the pain management specialist under fluoroscopy guidance. After this condition, the entry of the needle is marked and anaesthetised with local anaesthetic. After the entry of the gasserian ganglion with the radiofrequency needle, 10 cm long, the location is checked with sensory and motor stimulation. If the placement is correct, 70 degrees 70 seconds of radiofrequency thermocoagulation is applied. | Procedure or surgery | Patients treated with gasserian ganglion RFT for trigeminal neuralgia |
Primary outcome
Masseter muscle thickness
Time frame: Pre-procedural time
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Masseter muscle thickness
Time frame: Post-procedural first month
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Masseter muscle thickness
Time frame: Post-procedural third month
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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.
Tuba Tanyel Saraçoğlu, MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gasserian Ganglion Radiofrequency Thermocoagulation in people with Trigeminal Neuralgia and Gasserian Ganglion; Lesion, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burak Erken, MD (+0902129096000, burak_erken@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter muscle thickness (time frame: Pre-procedural time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.