ClinicalTrials.gg
Status unknownNCT03305289Updated Jul 28, 2020

FMRI Assessment After Radiofrequency in Trigeminal Neuralgia

An interventional study of pulsed Radiofrequency and thermal Radiofrequency in Trigeminal Neuralgia and Pain, Neuropathic, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Trigeminal Neuralgia
  • Pain, Neuropathic
03

In context

Trigeminal Neuralgia

140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 20 - 65 years
  • Primary trigeminal neuralgia
  • Maxillary and/or mandibular affection only
  • Failure of medical treatment

Exclusion criteria

Exclusion Criteria:

  • 2ry trigeminal neuralgia
  • Recurrent trigeminal neuralgia
  • Ophthalmic branch affection
  • for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,...)
  • Pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    pulsed radiofrequency

    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

    Procedure: pulsed Radiofrequency

  • Active comparator
    thermal Radiofrequency

    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

    Procedure: thermal Radiofrequency

Interventions

  • Procedurepulsed Radiofrequency

    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

  • Procedurethermal Radiofrequency

    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

06

What researchers measure

Primary outcomes

  1. pain alleviation

    pain assessment by functional MRI

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2020; primary completion for Oct 2021, 10 months later.

Of 33 non-industry interventional studies with no phase under Trigeminal Neuralgia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 10 months is below that.

Counting every sponsor, half of 33 studies reached it within 27 months; a quarter within 11 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2017
First posted
Oct 9, 2017
StartEst.
Dec 1, 2020
Primary completionEst.
Oct 30, 2021
CompletionEst.
Oct 30, 2022
Last update
Jul 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03305289
Lead sponsor
Assiut University
Responsible party
mohamed elsayed (assisstant lecture, Assiut University) — Principal investigator
First posted
Oct 9, 2017
Start date
Dec 1, 2020 (estimated)
Primary completion
Oct 30, 2021 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Jul 28, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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