NCT07811973

Brief 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). 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Sep 2028

Study Start

First participant enrolled

August 31, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 3, 2026

Last Update Submit

September 9, 2026

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

  • Bni (Barrow Neurological Institute) score improvement

    Pain free without medication

    2years

Study Arms (1)

Trigeminal neuralgia

EXPERIMENTAL

Arachnoid nerve detethering

Procedure: Arachnoid nerve detethering

Interventions

Arachnoid nerve detetheringPROCEDURE

Endoscopic assisted

Trigeminal neuralgia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more 18
  • Failed medical treatment

You may not qualify if:

  • Vascular compression
  • Tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohamed

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 10, 2026

Study Start

August 31, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share