NCT04117035

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

3.2 years

First QC Date

September 18, 2019

Last Update Submit

June 26, 2023

Conditions

Trigeminal NeuralgiaMultiple SclerosisPain

Keywords

multiple sclerosistrigeminal neuralgiaPainQuality of life

Outcome Measures

Primary Outcomes (2)

  • Barrow Neurological Institute (BNI) pain measure

    BNI Pain Scale (BNI-PS), 5-level categories (scale range: 1-5)

    6 MONTHS

  • Barrow Neurological Institute (BNI) numbness measure

    BNI Numbness Scale (BNI-NS), 5-level categories (scale range: 1-5)

    6 MONTHS

Secondary Outcomes (4)

  • Current medication and dosage

    12 MONTHS

  • Vision complications

    12 MONTHS

  • Motor impairment

    12 MONTHS

  • Cognitive impairment

    12 MONTHS

Study Arms (2)

Control arm

PLACEBO COMPARATOR

Standard care

Procedure: GKRS standard care

Intervention

EXPERIMENTAL
Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure

Interventions

Gamma Knife Radiosurgery (GKRS) personalised procedurePROCEDURE

Personalised GKRS treatment

Intervention
GKRS standard carePROCEDURE

Standard GKRS treatment

Control arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has idiopathic TN or MS-related TN.
  • Subject is available for follow up.
  • \. 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

You may not qualify if:

  • Patients who:
  • Have no capacity to complete written informed consent
  • Do not understand English
  • Repeat GKRS treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield royal hallamshire hospital

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Trigeminal NeuralgiaMultiple SclerosisPain

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jianhua Wu, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Wu, PhD

CONTACT

0113 343 3431j.h.wu@leeds.ac.uk

Sakina Edwebi, PhD

CONTACT

07825814912S.Edwebi@leeds.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-blinded randomised control pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor in Medical Statistics/Biostatistics

Study Record Dates

First Submitted

September 18, 2019

First Posted

October 7, 2019

Study Start

November 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)