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RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

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ClinicalTrials.gov Identifier: NCT02708810
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

Brief Summary:
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Device: Unframed Virtual Cone Radiation: 80 Gy Radiation Not Applicable

Detailed Description:
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Study Start Date : November 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
80 Gy Radiation & Unframed Virtual Cone
80 Gy Virtual Cone Radiosurgery unframed (face mask)
Device: Unframed Virtual Cone
A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. This will allow for very precise targeting. During the procedure, the study doctor will also confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask (unframed) will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on the painful nerve in the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 60 minutes. The face mask (unframed) will be removed after the treatment.
Other Name: Face Mask

Radiation: 80 Gy Radiation
Other Name: Radiosurgery




Primary Outcome Measures :
  1. Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment [ Time Frame: 3 Month Follow-Up Visit ]
  2. The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms. [ Time Frame: 1 Year ]
    Pain Relief Score designed to assess trigeminal neuralgia associated pain. It ranges from "I" being "no trigeminal pain, no medication" to "V" being "severe pain/no pain relief".


Secondary Outcome Measures :
  1. Number of Participants with treatment-related adverse events [ Time Frame: 1 Year ]
    Based on the assessments of the patient and the responses provided by the patient in questionnaires, we will assess acute and late neurologic toxicities. All adverse events/toxicities will be assessed with the utilization of CTCAE v.4.0.

  2. Mean of Quality of Life Scores as measured by SF-36 Questionnaire [ Time Frame: 1 Year ]
    Quality of Life (QOL) will be measured by SF-36. This questionnaire consists of 36 questions (items) measuring physical and mental health in relation to 8 health concepts: physical functioning, bodily pain, role of limitations due to physical health problems, role of limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perception. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively.

  3. Patient Satisfaction Scores [ Time Frame: 3 Month Follow-Up Visit ]
    3 months following the completion of radiosurgery, the patient will be asked the following two questions: 1) Would you have the radiosurgery procedure again? 2) Would you recommend it to friends and family?



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
  • Patients must have an ECOG status of 0, 1, or 2
  • Patients must be at least 18 years of age
  • Life expectancy must be greater than 12 months
  • MRI of brain within prior 12 months to confirm lack of other causes of facial pain
  • All patients must be given written informed consent

Exclusion Criteria:

  • Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
  • Patients with atypical trigeminal neuralgia or headache pain syndromes
  • Patients with pain associated with multiple sclerosis or base of skull tumor
  • Patients with medical contra-indications to MR imaging (e.g. pacemaker)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708810


Contacts
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Contact: Kristin K. Webb kriwebb@uab.edu

Locations
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United States, Alabama
Hazelrig-Salter Radiation Oncology Center Recruiting
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: John Fiveash, MD University of Alabama at Birmingham

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Responsible Party: John Fiveash, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02708810     History of Changes
Other Study ID Numbers: IRB-150608005
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Fiveash, MD, University of Alabama at Birmingham:
radiosurgery (RS)
trigeminal neuralgia (TGN)
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases