F45.41 R52.1
Conditions
Interventions
Group 1: The search is for quantitative changes of important brain metabolites in pain patients over the course of the 6-month cannabis pain therapy. Using MR spectroscopy, key metabolites of central
Sponsors
Universitätsklinikum des Saarlandes, Abteilung Neuroradiolgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic pain patients at the University Hospital of Saarland with planned cannabis therapy. A balanced ratio of male and female patients is aimed for.
Exclusion criteria
Exclusion criteria: - Minority - lack of capacity to consent - pregnancy - nicotine abuse - uncontrollable epilepsy - extreme claustrophobia - electromechanical devices in or on the body (e.g., pacemakers, defibrillators, neurostimulators, cochlear implants, drug pumps, etc.) - magnetizable implants (e.g., cochlear implants, stents and clips or coils, especially of the brain and head vessels) - diseases of the brain that can affect metabolism (e.g., (Alzheimer's) dementia) - inflammatory diseases of the brain (e.g., multiple sclerosis) - tumors or space-occupying lesions of the head - lack of consent to disclose incidental findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determination of the concentration values of important brain metabolites in pain patients at 3 different time points during the course of cannabis therapy: T0: before the start of cannabis therapy, T2: 3 months after the start of therapy, T4: 4 weeks after the end of therapy. 1.a. Concentration values of hydrogen-containing metabolites in the brain: • N-Acetylaspartate (NAA) • Choline (Cho) • Creatine (Cr) • Inositol (Ins) • Glutamate/Glutamine (Glx) 1.b. Concentration values of phosphorus-containing metabolites in the brain: • Phosphocreatine (PCr) • Adenosine triphosphate (ATP) • Inorganic phosphate (Pi) • Nicotinamide adenine dinucleotide (NAD) • Phosphomonoester (PME) • Phosphodiester (PDE) • pH value 2. Recording the quality of daily life of pain patients using validated score values from standardized questionnaires during the course of cannabis therapy: T0: before the start of therapy, T2: 3 months after the start of therapy, T3: 6 months after the start of therapy (end of therapy), T4: 4 weeks after the end of therapy. 2.a. Score values for patients' quality of life: • General quality of daily life: "World Health Organization Quality of Life, Short Form" (WHOQOL-BREF) • Aspects of pain experience: "Depression-Anxiety-Stress Scale" (DASS) • Assessment of physical complaints: "Screening for Somatoform Disorders, 7 Days" (SOMS-7T) • Assessment of therapy effect: "Patients’ Global Impression of Change" (PGIC) • Nociceptive and neuropathic components of pain perception: "Brief Pain Inventory" (BPI), "Neuropathic Pain Symptom Inventory" (NPSI) • Pain grading according to 'von Korff' • Insomnia complaints: "Insomnia Severity Index" (ISI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Search for possible correlations between detected changes in brain metabolism and the THC content in the blood. 4. Search for possible correlations between detected changes in quality of life and the THC content in the blood. 5. Search for possible correlations between detected changes in brain metabolism and changes in quality of life. 6. Evaluation of the influence of cannabis on individual sub-aspects of quality of life | — |
Countries
Germany
Contacts
Public ContactWolfgang Reith
Universitätsklinikum des Saarlandes, Abteilung Neuroradiologie
Outcome results
None listed