M54.5
Conditions
Interventions
Group 1: A conventional FUS stimulation targeting a common region (e.g., the anterior insula)
Group 2: A personalized FUS stimulation tailored to the individual cortical pain signatures of each patien
Sponsors
Klinikum der Universität München, Klinik und Poliklinik für Radiologie
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of chronic low back pain according to IASP criteria (>6 months duration) - Moderate to severe pain intensity (NRS) - Stable pain medication for at least 4 weeks - MRI compatibility - Neurological assessment without relevant findings - Ability to provide informed consent - Sufficient language and cognitive skills
Exclusion criteria
Exclusion criteria: - Age 60 - Pregnancy or breastfeeding - Severe neurological or psychiatric disorders - MRI contraindications - Unstable medical conditions - Recent participation in other studies - Unstable pain medication - Inability to provide consent - Ongoing unstable pain therapy or alternative treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity (numeric rating scale), cortical BOLD-fMRI activity, and cortical perfusion (ASL) in target regions before and after FUS stimulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in functional connectivity (rs-fMRI), targeting accuracy of FUS, GABA concentration (MRS), longitudinal pain intensity, and carry-over effect analysis | — |
Countries
Germany
Contacts
Public ContactEnrico Schulz
Klinikum der Universität München, Klinik und Poliklinik für Radiologie
Outcome results
None listed