Trigeminal NeuralgiaNCT04801407
Comparative Study inTreatment of Trigeminal Neuralgia
A study testing percutaneous radiofrequency trigeminal rhizotomy and Microvascular decompression of the trigeminal nerve in people with Trigeminal Neuralgia, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and Comparing between them according the different outcome parameters. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- percutaneous radiofrequency trigeminal rhizotomy and Microvascular decompression of the trigeminal nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2021to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Failed medical treatment more than 6 months
Who cannot join
- Coagulation disorder or hemorrhagic disease;
- Mental illness and inability to cooperate;
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mohamed Abdelsamee Ahmed
Sohag, Sohag City, 82514
roshdy elkhyat, +201223486390, mohamedneurosurgery33@gmail.com
abdin khair-allah, +201020196831, abdin_mail@yahoo.com
About this study
Official title: Comparative Study Between Microvascular Decompression and Percutaneous Radiofrequency Rhizotomy for Treatment of Trigeminal Neuralgia
This study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and Comparing between them according the different outcome parameters.
Read the detailed description
This is prospective case -series hospital based study, will be conducted on 40 patients with trigeminal neuralgia treated either by percutaneous radiofrequency trigeminal rhizotomy or microvascular decompression at Sohag University Hospitals, between march 2021 and June 2022 and we will divide the the patients into two groups ,one group will be treated with percutaneous radiofrequency trigeminal rhizotomy and the other group will be treated with microvascular decompression and we will asses the results with the Barrow Neurological Institute Pain Intensity Score .
- Conditions
- Trigeminal Neuralgia
- Being tested
- percutaneous radiofrequency trigeminal rhizotomy, Microvascular decompression of the trigeminal nerve
- Keywords
- trigeminal neuralgia
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous radiofrequency trigeminal rhizotomyProcedure or surgery
percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and
Microvascular decompression of the trigeminal nerveProcedure or surgery
Microvascular decompression is a procedure that decompress the nerve from vascular conflict
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency group | Active comparator | it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy Receives: Procedure: percutaneous radiofrequency trigeminal rhizotomy |
| Microvascular decompression group | Active comparator | it is the group that will be treated with Microvascular decompression Receives: Procedure: Microvascular decompression of the trigeminal nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barrow Neurological Institute Pain Intensity Score
I (no pain, no medication), II (occasional pain, not requiring medication), III (some pain, controlled with medication), IV (some pain, not controlled with medication) V (severe pain, no pain relief with medication).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 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 Sohag 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective case -series hospital based study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohmed abdelsamee ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801407
- Sponsor's protocol ID
- Soh-Med-21-03-06
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Microvascular Decompression and Percutaneous Radiofrequency Rhizotomy for Treatment of Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT04801407
- Acronym / sponsor ID
- Soh-Med-21-03-06
- Conditions
- Trigeminal Neuralgia
- Keywords
- trigeminal neuralgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Mar 2021 (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.
This study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and Comparing between them according the different outcome parameters.
Detailed description
This is prospective case -series hospital based study, will be conducted on 40 patients with trigeminal neuralgia treated either by percutaneous radiofrequency trigeminal rhizotomy or microvascular decompression at Sohag University Hospitals, between march 2021 and June 2022 and we will divide the the patients into two groups ,one group will be treated with percutaneous radiofrequency trigeminal rhizotomy and the other group will be treated with microvascular decompression and we will asses the results with the Barrow Neurological Institute Pain Intensity Score .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective case -series hospital based study
| Arm | Type | Receives |
|---|---|---|
| radiofrequency group | Active comparator | Procedure: percutaneous radiofrequency trigeminal rhizotomyit is the group that will be treated with Percutaneous Radiofrequency Rhizotomy |
| Microvascular decompression group | Active comparator | Procedure: Microvascular decompression of the trigeminal nerveit is the group that will be treated with Microvascular decompression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Failed medical treatment more than 6 months
Key exclusion criteria (2 listed)
- Coagulation disorder or hemorrhagic disease;
- Mental illness and inability to cooperate;
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 |
|---|---|---|
| percutaneous radiofrequency trigeminal rhizotomypercutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and | Procedure or surgery | radiofrequency group |
| Microvascular decompression of the trigeminal nerveMicrovascular decompression is a procedure that decompress the nerve from vascular conflict | Procedure or surgery | Microvascular decompression group |
Primary outcome
Barrow Neurological Institute Pain Intensity Score
Time frame: 3 months
I (no pain, no medication), II (occasional pain, not requiring medication), III (some pain, controlled with medication), IV (some pain, not controlled with medication) V (severe pain, no pain relief with medication).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous radiofrequency trigeminal rhizotomy and Microvascular decompression of the trigeminal nerve in people with Trigeminal Neuralgia, run by Sohag University at 1 site in Egypt.
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 2 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barrow Neurological Institute Pain Intensity Score (time frame: 3 months). 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 17 Mar 2021.