Last updated: October 3, 2023
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting
Phase
N/A
Condition
Headaches
Pain (Pediatric)
Pain
Treatment
GKRS-VR training
Control Group
Clinical Study ID
NCT05810428
GR-2021-12374601
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Any person unable to lie still within the environment of the MRI scanner for therequired 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 unsuitablefor the study.
Study Design
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: GKRS-VR training
Phase:
Study Start date:
April 06, 2023
Estimated Completion Date:
April 30, 2026
Connect with a study center
IRCCS San Raffaele
Milan, 20132
ItalyActive - Recruiting
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