Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis

Status Completed

Clinical Trial Summary

Clinical characteristics, neuroanatomical findings and efficacy of medical and surgical treatment of symptomatic trigeminal neuralgia - a systematic prospective study of 60 consecutive patients

Clinical Trial Description

Background Among patients with TN, approximately 15% has secondary TN caused by another underlying condition such as multiple sclerosis or a tumor. Studies of classical TN patients have shown a strong association between a severe NVC of the trigeminal nerve and the painful side. This association has been less investigated in STN.

There are no previous systemic and prospective studies of the underlying causes, characteristics and treatment response of patients with STN. Most existing studies on STN have various methodological drawbacks as inclusion was not prospective, diagnosis was not consistent with international guidelines, imaging techniques were not adequately advanced at the time of publication and evaluation of treatment efficacy was not performed by evaluators independent of the neurosurgeon.

Aims

1) To describe the clinical characteristics, the neuroanatomical findings using 3.0 Tesla MRI, and the efficacy of medical and surgical treatment in STN

Hypotheses

1. In STN, there is a correlation between demylinating brainstem plaques and presence and degree of neurovascular contact of the trigeminal nerve ipsilateral to the painful side

2. The efficacy of medical and surgical treatment of STN is comparable to the efficacy in patients with classical trigeminal neuralgia

Power calculations Sample size depends on the number of patients in the inclusion period. The estimated number of included patients is at least 60 patients.

Methods Data have been collected prospectively since 2012 based on semi-structured interview forms completed at out-patient visits at the Danish Headache Center. The efficacy of medical and surgical treatment was also documented prospectively by structured interviews. Efficacy of surgical treatment was evaluated by independent assessors.

All patients had a 3.0 Tesla MRI with a special protocol adapted for the trigeminal nerve and the brainstem.

Ethical considerations The treatment of patients with STN will not differ from the usual treatment and decision-taking. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04371575
Study type	Observational
Source	Danish Headache Center
Contact
Status	Completed
Phase
Start date	September 1, 2012
Completion date	December 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05528666` - Risk Perception in Multiple Sclerosis
Completed	`NCT03608527` - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis	N/A
Recruiting	`NCT05532943` - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis	Phase 1/Phase 2
Completed	`NCT02486640` - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed	`NCT01324232` - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis	Phase 2
Completed	`NCT04546698` - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting	`NCT04380220` - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed	`NCT02835677` - Integrating Caregiver Support Into MS Care	N/A
Completed	`NCT03686826` - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting	`NCT05964829` - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis	N/A
Withdrawn	`NCT06021561` - Orofacial Pain in Multiple Sclerosis
Completed	`NCT03653585` - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting	`NCT04798651` - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis	N/A
Active, not recruiting	`NCT05054140` - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis	Phase 2
Completed	`NCT05447143` - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis	N/A
Recruiting	`NCT06195644` - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients	Phase 1
Completed	`NCT04147052` - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis	N/A
Completed	`NCT03591809` - Combined Exercise Training in Patients With Multiple Sclerosis	N/A
Completed	`NCT03594357` - Cognitive Functions in Patients With Multiple Sclerosis
Completed	`NCT02845635` - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms