Classical Trigeminal Neuralgia and Sodium Channel Mutations

NCT03656497 | Completed

• 1 other identifier: H-15010165
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The most common cause of trigeminal neuralgia is considered to be a neurovascular contact. However, this etiological factor only seem to be present in half of the patient group. Thus the etiology of the other half is unknown. Gain-of function genetic mutations in voltage gated sodium channels have been hypothesized as playing a role in the etiology of trigeminal neuralgia but it has yet to be confirmed. In recent years gain-of-function mutations have been identified as a causative factor in other pain-diseases presenting with trigeminal neuralgia phenotypic similarities.

Conditions

Trigeminal Neuralgia

Keywords

genetic mutations, voltage gated sodium channels, phenotype,

Outcome Measures

Primary Outcomes (1)

• Exploratory study of association between phenotype and genotype of trigeminal neuralgia

  To identify genetic mutations, via Sanger Next Generation Sequencing, in either NaV 1.7, NaV1.8 or NaV1.9 encoding genes and link the findings to the phenotype of trigeminal neurlagia patients with a high genetic load.

  1 day

Interventions

Observational OTHER

No intervention is conducted as the study aim is to explore the link between pheno- and genetype of trigeminal neuralgia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from trigeminal neuralgia and has an onset of disease before the age of 42 and/or first-line relative with TN.

You may qualify if:

• Patients must be able to give Signed Informed Consent prior to study entry
• Patients fulfilling of the ICHD-3 beta diagnostic criteria for classical TN.1
• Age 18 years or older.
• Age at debut \< 42 years and/or confirmed first-line relative with TN.
• Respond to sodium channel blockers with a 50% reduction of pain intensity evaluated by both the patient and the examining physician using the visual analog scale (VAS).

You may not qualify if:

• Psychiatric or mental illness of physical condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.
• History of herpes zoster in the distribution of the trigeminal nerve ipsilateral to pain, multiple sclerosis or a space-occupying lesion.
• History indicative of painful posttraumatic trigeminal neuropathy such as previous trauma, surgery or radiation to the trigeminal nerve ipsilateral to pain.

Sponsors & Collaborators

• Danish Headache Center: lead
• Maastricht University Medical Center: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

full blood

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Lars Bendtsen, ass. prof.

  Danish Headache Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 4, 2018
• Study Start: November 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-08