Trigeminal NeuralgiaNCT04117035
A Personalised Radiosurgery Procedure for People With Trigeminal Neuralgia to Improve Pain, Quality of Life and Reduce Complications
A study testing Gamma Knife Radiosurgery (GKRS) personalised procedure in people with Trigeminal Neuralgia and Multiple Sclerosis, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate prospectively the feasibility and impact of personalised gamma knife radiosurgery treatment protocol versus current standard protocol for people with idiopathic or Multiple Sclerosis-related Trigeminal Neurolgia (MS related TN) on effectiveness in pain relief, the development of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trigeminal Neuralgia, Multiple Sclerosis, Pain
- What is being tested?
- Gamma Knife Radiosurgery (GKRS) personalised procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 31 Dec 2023
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has idiopathic TN or MS-related TN.
- Subject is available for follow up.
- 4. Subject can understand the informed consent form in English. 5. Age over 18 years at the time of signing the Informed Consent Form 6. Have been treatment planned to receive GKRS treatment
Who cannot join
- Patients who:
- Have no capacity to complete written informed consent
- Do not understand English
- Repeat GKRS treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield royal hallamshire hospital
Sheffield
Alison Loescher, PhD
About this study
Official title: A Personalised Radiosurgery Procedure for People With Trigeminal Neuralgia to Improve Pain, Quality of Life and Reduce Complications - a Confidence in Concept Pilot Study (PROMOTION)
The aim of this study is to evaluate prospectively the feasibility and impact of personalised gamma knife radiosurgery treatment protocol versus current standard protocol for people with idiopathic or Multiple Sclerosis-related Trigeminal Neurolgia (MS related TN) on effectiveness in pain relief, the development of morbidity and quality of life.
Patients with TN or MS-related TN are referred to the National Centre for Stereotactic Radiosurgery in Sheffield for clinical consultation, and will undergo gamma knife radiosurgery (GNRS) for treating trigeminal neuralgia if eligible. The GKRS treatment is provided as a standard National Health Service (NHS) routine care. The current procedure has been proven to be safe and effectiveness in reducing the pain caused by TN. The current GKRS treatment protocol performs the treatment on the trigeminal nerve close to the brainstem, which might result in higher complication rate (mainly facial numbness). This study will conduct a pilot randomised controlled trial to evaluate an alternative treatment protocol, which will perform the GKRS treatment at the retrogasserian zone (further away from the brainstem). This treatment protocol has been widely used in Europe and USA, and is safe and effective. Most studies adopting this protocol have shown less complication rate after treatment.
Read the detailed description
Trigeminal neuralgia (TN) is a condition of excruciating facial pain characterized by brief, repeated, electric shock-like pains. Like idiopathic TN, people with multiple sclerosis (MS) related TN (PwMSTN) often suffer from episodic facial pain (often excruciating) that may be related to demyelination of the trigeminal pathways. It is estimated that people with multiple sclerosis (PwMS) are 20 times more likely to present with TN symptoms than non-MS people and a recent review estimated that 4-8% of PwMS have TN. Patients with TN or MS-related TN who no longer respond to treatment often opt for non-invasive gamma knife radiosurgery (GKRS), with variable outcomes. Factors, such as patient characteristics, target treatment location and radiation dosage, could affect the efficacy of pain relief and result in post-surgical morbidity. There is no consensus of the best GKRS target treatment location or the optimal radiation dosage for GKRS treatment among centers, this results in great variability across centers in patient outcomes of pain control and morbidity. This prospective surgical pilot study will recruit PwTN and PwMS-related TN from the National Center for Stereotactic Radiosurgery, Sheffield, to evaluate the impact of a personalized GKRS treatment protocol on safety, efficacy (pain control) and morbidity. The personalized procedure will target the treatment location on trigeminal nerve further away from the brain stem as compared to the current standard treatment location that is closer to the brain stem. The personalized procedure may reduce the radiation dose to the brain stem and then reduce the adverse effects of the treatment. The recruited PwTN and PwMS-related TN will be randomly allocated to either the personalized GKRS treatment protocol group or the standard GKRS treatment protocol group. The efficacy in pain relief and morbidity will be evaluated between the treatment groups at 6 months and 12 months post-surgery.
This study does not have main ethical, legal issues. The GKRS treatment is provided as routine NHS care, and the study will only alter the treatment location for those patients who would normally go through the standardtreatment protocol. Therefor there will be no management issues.
Information collected during this study will be kept confidential. All data collected for this study will be kept safely and securely on secure NHS computer server and paper records at the clinic. All data will be handled strictly according to the University of Leeds privacy notice for research participants
- Conditions
- Trigeminal Neuralgia, Multiple Sclerosis, Pain
- Being tested
- Gamma Knife Radiosurgery (GKRS) personalised procedure, GKRS standard care
- Keywords
- multiple sclerosis, trigeminal neuralgia, Pain, Quality of life
- Medical subject headings
- Trigeminal Neuralgia, Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Knife Radiosurgery (GKRS) personalised procedureProcedure or surgery
Personalised GKRS treatment
GKRS standard careProcedure or surgery
Standard GKRS treatment
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Standard care Receives: Procedure: GKRS standard care |
| Intervention | Experimental | Not described Receives: Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barrow Neurological Institute (BNI) pain measure
BNI Pain Scale (BNI-PS), 5-level categories (scale range: 1-5)
Measured: 6 MONTHS
Barrow Neurological Institute (BNI) numbness measure
BNI Numbness Scale (BNI-NS), 5-level categories (scale range: 1-5)
Measured: 6 MONTHS
Secondary outcomes (4)
Current medication and dosage
Measured: 12 MONTHS
Vision complications
Recorded as adverse events such as blurred vision, double vision, or water eyes
Measured: 12 MONTHS
Motor impairment
Assessed through a battery of test with a performance score (range: 1-100)
Measured: 12 MONTHS
Cognitive impairment
Assessed through a battery of test with a performance score (range: 1-100)
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Nov 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2023 (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.
- 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
- Model description
- single-blinded randomised control pilot study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua Wu, University of Leeds
- Investigators
- Jianhua Wu, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117035
- Sponsor's protocol ID
- 255351
- Other IDs
- 115658
- Status last verified
- Jun 2023
- First submitted
- 18 Sep 2019
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalised Radiosurgery Procedure for People With Trigeminal Neuralgia to Improve Pain, Quality of Life and Reduce Complications - a Confidence in Concept Pilot Study (PROMOTION)
- ClinicalTrials.gov ID
- NCT04117035
- Acronym / sponsor ID
- 255351
- Conditions
- Trigeminal Neuralgia, Multiple Sclerosis, Pain
- Keywords
- multiple sclerosis, trigeminal neuralgia, Pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Oct 2019 (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.
The aim of this study is to evaluate prospectively the feasibility and impact of personalised gamma knife radiosurgery treatment protocol versus current standard protocol for people with idiopathic or Multiple Sclerosis-related Trigeminal Neurolgia (MS related TN) on effectiveness in pain relief, the development of morbidity and quality of life.
Patients with TN or MS-related TN are referred to the National Centre for Stereotactic Radiosurgery in Sheffield for clinical consultation, and will undergo gamma knife radiosurgery (GNRS) for treating trigeminal neuralgia if eligible. The GKRS treatment is provided as a standard National Health Service (NHS) routine care. The current procedure has been proven to be safe and effectiveness in reducing the pain caused by TN. The current GKRS treatment protocol performs the treatment on the trigeminal nerve close to the brainstem, which might result in higher complication rate (mainly facial numbness). This study will conduct a pilot randomised controlled trial to evaluate an alternative treatment protocol, which will perform the GKRS treatment at the retrogasserian zone (further away from the brainstem). This treatment protocol has been widely used in Europe and USA, and is safe and effective. Most studies adopting this protocol have shown less complication rate after treatment.
Detailed description
Trigeminal neuralgia (TN) is a condition of excruciating facial pain characterized by brief, repeated, electric shock-like pains. Like idiopathic TN, people with multiple sclerosis (MS) related TN (PwMSTN) often suffer from episodic facial pain (often excruciating) that may be related to demyelination of the trigeminal pathways. It is estimated that people with multiple sclerosis (PwMS) are 20 times more likely to present with TN symptoms than non-MS people and a recent review estimated that 4-8% of PwMS have TN. Patients with TN or MS-related TN who no longer respond to treatment often opt for non-invasive gamma knife radiosurgery (GKRS), with variable outcomes. Factors, such as patient characteristics, target treatment location and radiation dosage, could affect the efficacy of pain relief and result in post-surgical morbidity. There is no consensus of the best GKRS target treatment location or the optimal radiation dosage for GKRS treatment among centers, this results in great variability across centers in patient outcomes of pain control and morbidity. This prospective surgical pilot study will recruit PwTN and PwMS-related TN from the National Center for Stereotactic Radiosurgery, Sheffield, to evaluate the impact of a personalized GKRS treatment protocol on safety, efficacy (pain control) and morbidity. The personalized procedure will target the treatment location on trigeminal nerve further away from the brain stem as compared to the current standard treatment location that is closer to the brain stem. The personalized procedure may reduce the radiation dose to the brain stem and then reduce the adverse effects of the treatment. The recruited PwTN and PwMS-related TN will be randomly allocated to either the personalized GKRS treatment protocol group or the standard GKRS treatment protocol group. The efficacy in pain relief and morbidity will be evaluated between the treatment groups at 6 months and 12 months post-surgery.
This study does not have main ethical, legal issues. The GKRS treatment is provided as routine NHS care, and the study will only alter the treatment location for those patients who would normally go through the standardtreatment protocol. Therefor there will be no management issues.
Information collected during this study will be kept confidential. All data collected for this study will be kept safely and securely on secure NHS computer server and paper records at the clinic. All data will be handled strictly according to the University of Leeds privacy notice for research participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single-blinded randomised control pilot study
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Procedure: GKRS standard careStandard care |
| Intervention | Experimental | Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has idiopathic TN or MS-related TN.
- Subject is available for follow up.
- 4. Subject can understand the informed consent form in English. 5. Age over 18 years at the time of signing the Informed Consent Form 6. Have been treatment planned to receive GKRS treatment
Key exclusion criteria (4 listed)
- Have no capacity to complete written informed consent
- Do not understand English
- Repeat GKRS treatment
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 |
|---|---|---|
| Gamma Knife Radiosurgery (GKRS) personalised procedurePersonalised GKRS treatment | Procedure or surgery | Intervention |
| GKRS standard careStandard GKRS treatment | Procedure or surgery | Control arm |
Primary outcome
Barrow Neurological Institute (BNI) pain measure
Time frame: 6 MONTHS
BNI Pain Scale (BNI-PS), 5-level categories (scale range: 1-5)
Barrow Neurological Institute (BNI) numbness measure
Time frame: 6 MONTHS
BNI Numbness Scale (BNI-NS), 5-level categories (scale range: 1-5)
4 secondary outcomes
Current medication and dosage
Time frame: 12 MONTHS
Vision complications
Time frame: 12 MONTHS
Motor impairment
Time frame: 12 MONTHS
Cognitive impairment
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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.
Jianhua Wu, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Knife Radiosurgery (GKRS) personalised procedure in people with Trigeminal Neuralgia and Multiple Sclerosis, run by University of Leeds at 1 site in United Kingdom.
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 3 inclusion and 4 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 27 Jun 2023. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Contact Jianhua Wu, PhD (0113 343 3431, j.h.wu@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barrow Neurological Institute (BNI) pain measure (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. 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 27 Jun 2023.