Using AI and Virtual Reality to Improve Pain Relief in Trigeminal Neuralgia
Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
This study is testing whether combining a special surgery with virtual reality training can help people with trigeminal neuralgia feel less pain compared to just having the surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05810428 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Gamma Knife radiosurgery (GKRS) combined with virtual reality (VR) training compared to GKRS alone in patients with trigeminal neuralgia (TN). The researchers will also utilize MRI and artificial intelligence to identify brain abnormalities that may predict treatment outcomes. By personalizing treatment based on brain-based biomarkers and clinical features, the study seeks to enhance pain relief for patients who do not respond adequately to standard therapies. This prospective randomized comparative approach could lead to significant advancements in managing TN.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with trigeminal neuralgia who are indicated for radiosurgical treatment.
Not a fit: Patients with significant psychiatric diseases, contraindications for MRI, or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide improved pain relief options for patients with trigeminal neuralgia who have not responded to conventional treatments.
How similar studies have performed: While the combination of AI and VR in pain management is an emerging field, similar approaches have shown promise in other pain-related conditions, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of TN according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria; * age \>18 years; * indication to undergo radiosurgical treatment; * willingness and ability to comply with scheduled visits and other trial procedures. Exclusion Criteria: * Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated; * metal implants, pacemaker, etc.; * Pregnancy or breastfeeding; * Any significant psychiatric disease; * Use of illicit drugs; * Brain pathology shown by brain MRI and/or neurophysiological examination; * Any person unable to understand and follow the instructions of the investigators; * Any other condition according to the Investigator would make the subject unsuitable for the study.
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Massimo Filippi, MD
- Email: filippi.massimo@hsr.it
- Phone: 00390226433054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.