Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01364272
Other study ID # SU-05252011-7807
Secondary ID IRB 15136
Status Completed
Phase
First received
Last updated
Start date September 2008
Est. completion date September 2010

Study information

Verified date October 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring about pain relief and facial numbness, we are conducting a study in which brain MRI scans will be done following stereotactic radiosurgery to learn if there are any changes in the MRI scans that correlate with symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are 1) intolerant of or refractory to medical management and 2) not candidates for or refusing a surgical micro-vascular decompression, will be evaluated for treatment with SRS. - ECOG or Karnofsky Performance Status will not be employed, but patients must be sufficiently healthy to tolerate all study procedures. - Patient must exhibit the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: - Exclusion criteria - Patients who present with pre-existing facial numbness. - Patients MRI contraindications (e.g., pacemaker or defibrillator, cochlear implant, brain aneurysm clip, etc.) - Patients who have previously been treated with MVD. - Patients who have previously had an ablative treatment, including prior SRS. - Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary DTI MRI findings DTI MRI will be performed before and after radiosurgery to determine if there is a correlation between pain relief, facial numbness, and imaging changes. 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05152368 - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy Phase 1
Recruiting NCT02801630 - An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia N/A
Completed NCT02473016 - Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia Phase 2
Recruiting NCT01364259 - A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia Phase 3
Completed NCT00603694 - Hippocampal Radiation Exposure and Memory N/A
Completed NCT00913107 - Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia Phase 2/Phase 3
Recruiting NCT04996199 - Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial Phase 4
Completed NCT06240494 - Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
Completed NCT05712993 - Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers N/A
Completed NCT04371575 - Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients
Completed NCT03669744 - Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
Completed NCT05032573 - Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia N/A
Recruiting NCT05615714 - Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial) Phase 1/Phase 2
Recruiting NCT04054024 - Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia Phase 2
Not yet recruiting NCT05451251 - Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion N/A
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Withdrawn NCT01932255 - CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap N/A
Completed NCT05075707 - Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia N/A
Completed NCT06334796 - Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology Early Phase 1
Recruiting NCT03331913 - Botulinum Toxin for Trigeminal Neuralgia Phase 3