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Trial record 1 of 9 for:    Recruiting Studies | Trigeminal Neuralgia | United States
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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 22, 2021
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE March 15, 2016
Last Update Posted Date September 22, 2021
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
  • Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment [ Time Frame: 3 Month Follow-Up Visit ]
  • 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".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
  • 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.
  • 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.
  • 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?
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
  • 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.
  • 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.
  • Patient Satisfaction Scores between the two arms [ 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?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Official Title  ICMJE RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Brief Summary To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuralgia
Intervention  ICMJE
  • 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
Study Arms  ICMJE 80 Gy Radiation & Unframed Virtual Cone
80 Gy Virtual Cone Radiosurgery unframed (face mask)
Interventions:
  • Device: Unframed Virtual Cone
  • Radiation: 80 Gy Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laronica K. Conway laronicaconway@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02708810
Other Study ID Numbers  ICMJE IRB-150608005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Fiveash, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Fiveash, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP