Trigeminal NeuralgiaNCT03305289
FMRI Assessment After Radiofrequency in Trigeminal Neuralgia
A study testing pulsed Radiofrequency and thermal Radiofrequency in people with Trigeminal Neuralgia and Pain, Neuropathic, run by Assiut University.
Trial summary
To investigate the brain activations related to TN, using fMRI, and to evaluate changes in these activations following the application of pulsed and thermal Radiofrequency lesioning to the gasserien ganglion. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Trigeminal Neuralgia, Pain, Neuropathic
- What is being tested?
- pulsed Radiofrequency and thermal Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 30 Oct 2022
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 - 65 years
- Primary trigeminal neuralgia
- Maxillary and/or mandibular affection only
- Failure of medical treatment
Who cannot join
- 2ry trigeminal neuralgia
- Recurrent trigeminal neuralgia
- Ophthalmic branch affection
- Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,…)
- Pregnancy
About this study
Official title: Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia
To investigate the brain activations related to TN, using fMRI, and to evaluate changes in these activations following the application of pulsed and thermal Radiofrequency lesioning to the gasserien ganglion.
- Conditions
- Trigeminal Neuralgia, Pain, Neuropathic
- Being tested
- pulsed Radiofrequency, thermal Radiofrequency
- Medical subject headings
- Trigeminal Neuralgia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed RadiofrequencyProcedure or surgery
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
thermal RadiofrequencyProcedure or surgery
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
| Study group | Role | What they receive |
|---|---|---|
| pulsed radiofrequency | Active comparator | sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins Receives: Procedure: pulsed Radiofrequency |
| thermal Radiofrequency | Active comparator | sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds Receives: Procedure: thermal Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain alleviation
pain assessment by functional MRI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Dec 2020 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed elsayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305289
- Sponsor's protocol ID
- RF in trigeminal neuralgia
- Status last verified
- Jul 2020
- First submitted
- 22 Sep 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT03305289
- Acronym / sponsor ID
- RF in trigeminal neuralgia
- Conditions
- Trigeminal Neuralgia, Pain, Neuropathic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 9 Oct 2017 (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.
To investigate the brain activations related to TN, using fMRI, and to evaluate changes in these activations following the application of pulsed and thermal Radiofrequency lesioning to the gasserien ganglion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulsed radiofrequency | Active comparator | Procedure: pulsed Radiofrequencysensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins |
| thermal Radiofrequency | Active comparator | Procedure: thermal Radiofrequencysensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 - 65 years
- Primary trigeminal neuralgia
- Maxillary and/or mandibular affection only
- Failure of medical treatment
Key exclusion criteria (5 listed)
- 2ry trigeminal neuralgia
- Recurrent trigeminal neuralgia
- Ophthalmic branch affection
- Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,…)
- Pregnancy
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 |
|---|---|---|
| pulsed Radiofrequencysensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins | Procedure or surgery | pulsed radiofrequency |
| thermal Radiofrequencysensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds | Procedure or surgery | thermal Radiofrequency |
Primary outcome
pain alleviation
Time frame: 1 month
pain assessment by functional MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed Radiofrequency and thermal Radiofrequency in people with Trigeminal Neuralgia and Pain, Neuropathic, run by Assiut University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Jul 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?
Results are not available in the source record.
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?
pain alleviation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.