Trigeminal NeuralgiaNCT07811973
Management of Arachnoid Nerve Tethering in Trigeminal Neuralagia
A study testing Arachnoid nerve detethering in people with Trigeminal Neuralgia, run by Assiut University.
Trial summary
This study aims to evaluate the clinical significance of arachnoid-trigeminal nerve conflict in patients with medically refractory trigeminal neuralgia without demonstrable neurovascular conflict on preoperative magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Arachnoid nerve detethering
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 30 Sep 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more 18
- Failed medical treatment
Who cannot join
- Vascular compression
- Tumors
About this study
Official title: Management of arachnoid_nerve Tethering in Trigeminal Neuralgia
This study aims to evaluate the clinical significance of arachnoid-trigeminal nerve conflict in patients with medically refractory trigeminal neuralgia without demonstrable neurovascular conflict on preoperative magnetic resonance imaging (MRI). Patients undergoing surgical exploration will be assessed clinically, radiologically, and intraoperatively for the presence and characteristics of arachnoid adhesions or tethering involving the trigeminal nerve. Endoscopic-assisted arachnoid release will be performed when appropriate. Postoperative pain outcome will be evaluated using the Barrow Neurological Institute (BNI) pain intensity score and the Visual Analog Scale (VAS). Recurrence, postoperative complications, MRI-intraoperative correlation, and potential predictors of favorable surgical outcome will also be evaluated.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Arachnoid nerve detethering
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arachnoid nerve detetheringProcedure or surgery
Endoscopic assisted
| Study group | Role | What they receive |
|---|---|---|
| Trigeminal neuralgia | Experimental | Arachnoid nerve detethering Receives: Procedure: Arachnoid nerve detethering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bni (Barrow Neurological Institute) score improvement
Pain free without medication
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2028 (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.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Amgad Kotb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811973
- Sponsor's protocol ID
- Anc in trigeminal neuaralagia
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of arachnoid_nerve Tethering in Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT07811973
- Acronym / sponsor ID
- Anc in trigeminal neuaralagia
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Sep 2026 (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 evaluate the clinical significance of arachnoid-trigeminal nerve conflict in patients with medically refractory trigeminal neuralgia without demonstrable neurovascular conflict on preoperative magnetic resonance imaging (MRI). Patients undergoing surgical exploration will be assessed clinically, radiologically, and intraoperatively for the presence and characteristics of arachnoid adhesions or tethering involving the trigeminal nerve. Endoscopic-assisted arachnoid release will be performed when appropriate. Postoperative pain outcome will be evaluated using the Barrow Neurological Institute (BNI) pain intensity score and the Visual Analog Scale (VAS). Recurrence, postoperative complications, MRI-intraoperative correlation, and potential predictors of favorable surgical outcome will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trigeminal neuralgia | Experimental | Procedure: Arachnoid nerve detetheringArachnoid nerve detethering |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more 18
- Failed medical treatment
Key exclusion criteria (2 listed)
- Vascular compression
- Tumors
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 |
|---|---|---|
| Arachnoid nerve detetheringEndoscopic assisted | Procedure or surgery | Trigeminal neuralgia |
Primary outcome
Bni (Barrow Neurological Institute) score improvement
Time frame: 2years
Pain free without medication
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Arachnoid nerve detethering in people with Trigeminal Neuralgia, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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?
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?
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?
Bni (Barrow Neurological Institute) score improvement (time frame: 2years). 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 10 Sep 2026.