Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
ConditionTrigeminal Neuralgia (TN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
The goal of this clinical trial is to evaluate Gamma Knife stereotactic radiosurgery (GK-SRS) as an ultra-early treatment option for trigeminal neuralgia (TN).
The main questions it aims to answer are:
1. will earlier GK-SRS provide more durable pain relief compared to later GK-SRS? 2. will earlier GK-SRS reduce or eliminate the need for high-dose medical therapy? 3. will earlier GK-SRS have a lower risk of serious complications compared to other first-line treatments?
If participants are assigned to GK-SRS treatment group, they will be asked to:
• Undergo a preoperative MRI, measurements of heart rate and blood pressure, stereotactic head-frame placement, post-operative management and observation.
Both groups will be asked to:
* Complete medical histories and neurological examinations. These are part of standard of care. * Participants will be asked a series of questions related to overall physical health, pain severity, and mood. Completing these questionnaires is part of the research activity. It will take approximately 15- 30 minutes to complete. These questionnaires include: The Barrow Neurological Institute Pain Intensity Score, Brief Pain Inventory-Facial (BPI-Facial), Visual Analog Scale (VAS), Medication Quantification Scale (MQS), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Short Form Health Survey.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Clinical diagnosis of classical or idiopathic TN, based on clinical history and MRI scan
Clinical diagnosis within 2 years prior to enrolment
Not deemed medically refractory (defined as adequate pain control despite ≥2 medication trials of adequate dose. Adequate pain control is defined as pain that is considered acceptably controlled by both the patient and treating neurologist, without the need for further dose escalation)
Disqualifiers
Secondary TN
Bilateral TN
Any contraindications to undergoing GK-SRS
Any prior cranial radiation
Trial design
Design model
Parallel
Treatments tested in this trial
GK SRS
Procedure/SurgeryUnder local anaesthesia, a Leksell stereotactic head frame is fixed to the patient's head to allow for complete cranial immobilization during treatment. The retrogasserian (i.e., mid-cisternal) target will be utilized at a single 4 mm isocenter, and 40 Gy will be administered to the 50% isodose line while limiting the brainstem to 12 Gy.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Standard armNo intervention 0 interventions
Group B: Gamma Knife stereotactic radiosurgery for TNExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary outcome measure--pain
The primary endpoint is satisfactory pain control at 2 years after GK-SRS treatment (for Experimental Arm) or 2 years after enrolment in the Non-intervention Arm, measured using Barrow Neurological Institute Facial Pain Scale (BNI). Satisfactory pain control = BNI I, II, IIIa Barrow Neurological Institute Facial Pain Scale (BNI) I - no pain, no medication II - occasional pain, no medication required III - some pain, adequately controlled with medication IIIa - no pain, continued medication IIIb - persistent pain, controlled with medication IV - some pain, not adequately controlled with medications V - severe pain or no pain relief (lower scores indicate better outcome)
Time frame
2 years after the day of GK-SRS treatment, for participants in the Experimental Arm. 2 years after enrolment, for participants in the No-intervention Arm.Secondary outcomes
1
Secondary outcome measure - treatment-related adverse events
Worst incidence of treatment-related adverse events by treatment arm. Adverse events will be determined using the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Time frame
At 6, 12, 24 months, and 5 years after the day of GK-SRS treatment, for participants in the Experimental Arm. At 6, 12, 24 months, and 5 years after enrolment, for participants in the No-intervention Arm2
Secondary outcome measure - medication
Pain medication equivalent dose measured with the Medication Quantification Scale version III (lower scores indicate better outcome)
Time frame
Experimental Arm: Baseline visit; GK-SRS treatment visit; follow-up visits 6, 12, 24 months, and 5 years after day of GK-SRS treatment. No-intervention Arm: Baseline visit; follow-up visits 6, 12, 24 months, and 5 years after enrolment3
Secondary outcome measure - complete pain relief
Score of 'BNI I' on the Barrow Neurological Institute Facial Pain Scale (BNI) Barrow Neurological Institute Facial Pain Scale (BNI) I - no pain, no medication II - occasional pain, no medication required III - some pain, adequately controlled with medication IIIa - no pain, continued medication IIIb - persistent pain, controlled with medication IV - some pain, not adequately controlled with medications V - severe pain or no pain relief (lower BNI score indicates better outcome)
Time frame
2 years after the day of GK-SRS treatment4
Secondary Outcome Measure - long term satisfactory pain relief
Proportion of patients with satisfactory pain control at 5 years after Gamma Knife treatment, measured using Barrow Neurological Institute Facial Pain Scale (BNI). Satisfactory pain control = BNI I, II, IIIa Barrow Neurological Institute Facial Pain Scale (BNI) I - no pain, no medication II - occasional pain, no medication required III - some pain, adequately controlled with medication IIIa - no pain, continued medication IIIb - persistent pain, controlled with medication IV - some pain, not adequately controlled with medications V - severe pain or no pain relief (lower scores indicate better outcome)
Time frame
5 years after day of GK-SRS treatmentSponsors and contacts
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Source ClinicalTrials.gov