Trigeminal NeuralgiaNCT04371575
Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients
An observational study of Trigeminal Neuralgia and Multiple Sclerosis, run by Stine Maarbjerg, MD PhD.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trigeminal Neuralgia, Multiple Sclerosis, Pain, Neuropathic
- What is being tested?
- Carbamazepine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2012to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical cohort of patients diagnosed with secondary trigeminal neuralgia attributed to multiple sclerosis at the Danish Headache Center
Who may be able to join
- Diagnosis of secondary trigeminal neuralgia attributed to multiple sclerosis
Who cannot join
None listed.
About this study
Official title: Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - Clinical Characteristics, Neuroanatomical Abnormalities and Treatment Efficacy
Clinical characteristics, neuroanatomical findings and efficacy of medical and surgical treatment of symptomatic trigeminal neuralgia - a systematic prospective study of 60 consecutive patients
Read the detailed 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
- To describe the clinical characteristics, the neuroanatomical findings using 3.0 Tesla MRI, and the efficacy of medical and surgical treatment in STN
Hypotheses
- 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
- 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.
- Conditions
- Trigeminal Neuralgia, Multiple Sclerosis, Pain, Neuropathic
- Being tested
- Carbamazepine
- Medical subject headings
- Trigeminal Neuralgia, Multiple Sclerosis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Also called Oxcarbazepine
There is no actual intervention as the study is observational. First choice tratment is Carbamzepine and Oxcarbazepine. In medically refractory patients, first choice surgery is microvascular decompression
What is being measured
The primary outcome is the main question the study is designed to answer.
Demyelinating brainstem plaques and neurovascular contact
In STN, there is a correlation between demyelinating brainstem plaques and presence and degree of neurovascular contact of the trigeminal nerve ipsilateral to the painful side
Measured: 2012-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Sep 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stine Maarbjerg, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stine Maarbjerg, MD PhD, Danish Headache Center
- Investigators
- Lars Bendtsen, Dr Med Sci, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371575
- Sponsor's protocol ID
- 010919
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noory N, Smilkov EA, Frederiksen JL, Heinskou TB, Andersen ASS, Bendtsen L, Maarbjerg S. Neurovascular contact plays no role in trigeminal neuralgia secondary to multiple sclerosis. Cephalalgia. 2021 Apr;41(5):593-603. doi: 10.1177/0333102420974356. Epub 2020 Nov 28.
PubMed 33249870
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - Clinical Characteristics, Neuroanatomical Abnormalities and Treatment Efficacy
- ClinicalTrials.gov ID
- NCT04371575
- Acronym / sponsor ID
- 010919
- Conditions
- Trigeminal Neuralgia, Multiple Sclerosis, Pain, Neuropathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stine Maarbjerg, MD PhDUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 May 2020 (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.
Clinical characteristics, neuroanatomical findings and efficacy of medical and surgical treatment of symptomatic trigeminal neuralgia - a systematic prospective study of 60 consecutive patients
Detailed 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
- To describe the clinical characteristics, the neuroanatomical findings using 3.0 Tesla MRI, and the efficacy of medical and surgical treatment in STN
Hypotheses
- 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
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical cohort of patients diagnosed with secondary trigeminal neuralgia attributed to multiple sclerosis at the Danish Headache Center
Key inclusion criteria (1 listed)
- Diagnosis of secondary trigeminal neuralgia attributed to multiple sclerosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CarbamazepineAlso: OxcarbazepineThere is no actual intervention as the study is observational. First choice tratment is Carbamzepine and Oxcarbazepine. In medically refractory patients, first choice surgery is microvascular decompression | Drug | – |
Primary outcome
Demyelinating brainstem plaques and neurovascular contact
Time frame: 2012-2019
In STN, there is a correlation between demyelinating brainstem plaques and presence and degree of neurovascular contact of the trigeminal nerve ipsilateral to the painful side
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 33249870Noory N, Smilkov EA, Frederiksen JL, Heinskou TB, Andersen ASS, Bendtsen L, Maarbjerg S. Neurovascular contact plays no role in trigeminal neuralgia secondary to multiple sclerosis. Cephalalgia. 2021 Apr;41(5):593-603. doi: 10.1177/0333102420974356. Epub 2020 Nov 28.
- 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. This study is not recruiting at the moment.
Lars Bendtsen, Dr Med Sci principal investigator
Danish Headache Center
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia and Multiple Sclerosis, run by Stine Maarbjerg, MD PhD.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 1 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demyelinating brainstem plaques and neurovascular contact (time frame: 2012-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371575, which also lists 1 linked publication.
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 1 May 2020; AzTrials last refreshed its copy on 3 Nov 2026.