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Clinical Study on the Diagnostic Accuracy of Trigeminal Somatosensory Evoked Potentials (TSEP) in the Diagnosis of Trigeminal Nerve Lesions

Clinical Study on the Diagnostic Accuracy of Trigeminal Somatosensory Evoked Potentials (TSEP) in the Diagnosis of Trigeminal Nerve Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123972
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-11
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Nerve Dysfunction / Trigeminal Neuropathy

Interventions

Gold Standard:Comprehensive clinical diagnostic criteria of "Expert consensus on diagnosis and treatment of idiopathic and secondary trigeminal neuralgia (2025 version)". It is specifically defined as
Index test:Trigeminal somatosensory evoked potential

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Case group inclusion criteria: those who met the following conditions were included in the case group: 1.Age of 18-75 years old, both sexes, able to cooperate to complete TSEP detection and related data collection; 2.The presence of clinical symptoms or signs suggestive of trigeminal neuropathy, including but not limited to facial hypoesthesia Or paresthesia, paroxysmal stinging/burning pain, chewing weakness, abnormal corneal reflex, etc., and the symptoms persist Time =1 week; 3.suspected or confirmed trigeminal nerve according to the clinical comprehensive diagnostic process (the gold standard of this study) Lesions, the type of lesions can include central (such as cerebrovascular diseases, demyelinating lesions, etc.) or peripheral Sex (such as nerve compression, inflammation, trauma, etc.); 4.no invasive treatment (e.g., nerve block or surgery) for trigeminal neuropathy before enrollment; 5.Maintain a relatively stable medication regimen for at least 2 weeks if they have already received drug therapy; 6.signed the informed consent form voluntarily with good compliance, and were able to cooperate to complete the study test. The inclusion criteria of healthy control group were as follows: 1) Age of 18-75 years old, both sexes, able to cooperate to complete TSEP detection and related data collection; 2) Patients visited the hospital at the same time without obvious abnormalities in related examinations; 3) There was no facial paresthesia, paroxysmal or persistent facial pain, chewing weakness or other symptoms or signs suggestive of trigeminal neuropathy; 4) Neurological examination showed that the sensory, motor and related reflex functions of the trigeminal nerve distribution area were normal; 5) No history of diseases known to affect the function of the trigeminal nerve: no history of central or peripheral nervous system diseases (such as cerebrovascular diseases, intracranial tumors, multiple sclerosis, craniocerebral trauma, etc.) and no systemic diseases that could cause neurological dysfunction (such as diabetes, uremia, etc.) were confirmed by detailed medical history and review of previous medical records. 6) no use of drugs that may affect nerve conduction function (such as antiepileptic drugs, sedative-hypnotics, or drugs with definite neurotoxicity) within 3 months before enrollment; 7) no clear history of central or peripheral nervous system diseases; 8) Informed consent was signed voluntarily with good compliance.

Exclusion criteria

Exclusion criteria: 1.Concomitant diseases affecting involuntary movement or maintenance of immobility of facial muscles, such as Meige syndrome, Hemifacial spasm, orofacial dystonia, severe tic disorders, etc. may interfere with TSEP detection Intraoperative stimulation, electrode stability and waveform interpretation; 2.combined with other cranial neuropathy that significantly affects facial sensation or pain assessment (such as glossopharyngeal neuralgia), As a result, it is difficult to determine the trigeminal nerve dysfunction alone. 3.complicated with serious systemic diseases (such as severe heart, liver, kidney dysfunction, active malignant tumor) The researchers thought that it might affect the neurological function or be unable to cooperate with the test; 4.pregnant or lactating women; 5.with obvious cognitive impairment, severe mental illness or disturbance of consciousness, unable to understand the study content or cooperate with the test; 6.The presence of skin damage, infection or fixed metal implants in the head, affecting electrode placement or signal acquisition; 7.severe head trauma, intracranial surgery, or acute cerebrovascular event within 3 months before enrollment; 8.long-term use of drugs that significantly affect neurophysiological signals and cannot be maintained stably; 9.Allergy to the electrodes or conductive materials used in the test, or inability to complete the standardized test due to limited posture or movement; 10.patients with a definite history of epilepsy or a high risk of seizures were considered by the investigator to be ineligible for stimulation electrophysiological study.

Design outcomes

Primary

MeasureTime frame
Trigeminal Somatosensory Evoked Potential (TSEP);

Countries

China

Contacts

Public ContactXiong Qiyuan

Zhongshan Hospital, Fudan University

xiong.qiyuan@zs-hospital.sh.cn+86 21 64043629

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026