Healthy Participants
Conditions
Interventions
Group 1: A single-dose Levodopa/Carbidopa (100/25mg) + Domperidon 10mg. Medication is given under supervision 60 minutes before testing.
After receiving the medication at day one of the study, the pa
Sponsors
Universitätsklinikum Essen, Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: • Healthy. • Age 18 to 40 years. • for women: hormonal contraception. • Written informed consent.
Exclusion criteria
Exclusion criteria: • Signs of renal, cardiovascular, or hepatic disease. • Signs of raised intraocular pressure. • Protein-rich diet before study-visit one. • History of, or present neurologic disorders, e.g. pain disorders, migraine, lower back pain, irritable bowel syndrome, cranial trauma, epilepsia, or sleep disorder. • History of, or present psychiatric disorder, e.g. depression, schizophrenia, substance abuse, or personality disorders. • History of, or present severe internal disorders, such as diabetes, neoplasia, thyroid dysfunction, asthma. • Acute infections (common cold, diarrhea). • Alcohol consumtion at the day of or the day before study participation. • Known allergy against any constituent of the study medication. • Surgery requiring narcosis within the last 6 months. • Participation in any study requiring the intake of study medication within the last 6 months. • Any long-term medication, except dietary supplements and hormonal contraception. • Intake of pain medication (e.g. NSAIDs) within the last 14 days. • For women: Pregnancy. • Disorders of the skin that could affect temperature sensation (e.g. neurodermitis). • Abnormal pain- or temperature sensitivity at the forearm, defined as : o Heat pain threshold > 50°C. o Warmth detection threshold >37°C. o Unstable heat pain ratings Unzuverlässige Differenzierung von Hitzereizen or VAS4048.5°C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome variable: Heat pain ratings (visal analog scale, 101-points) obtained for the skin patches with placebo treatment and the skin patch with control treatment at identical stimulus intensities. Outcome comparison: The interaction effect between factors Group (between-subject, levels: LDopa, Placebo) and Patch (within-subject, levels: Placebo-Treatment, Control-Treatment) tested in a full-factorial Mixed-Model ANOVA with maximum random effects structure. | — |
Countries
Germany
Contacts
Public ContactMatthias Zunhammer
Universitätsklinikum Essen, Klinik für Neurologie
Outcome results
None listed