Pijn Pain
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Healthy male subjects aged 18-40 years, inclusive; healthy is defined as no clinically relevant abnormalities identified. * Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: * History of symptoms or any significant including (but not limited to) neurological or psychiatric disorder., if assessed by the Principal Investigator as possibly interfering with the study objectives. * High pain tolerance (80% or higher value for the pain tolerance of the electrical stair test) * Presence of Virtual Reality Sickness (simulator sickness). * Smoker of more than 5 cigarettes per day prior to screening or who use tobacco products equivalent to more than 5 cigarettes per day. * Consume, on average, > 8 units/day of (methyl)-xanthines (e.g. coffee, tea, cola, chocolate) or not able to refrain from use during each stay at the CHDR clinic. * Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Electrical Stair: PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test VAS (mm). * Electrical Stair (including virtual reality simulation without enhancement): PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test VAS (mm). * Electrical Stair (including virtual reality simulation with enhancement): PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test VAS (mm). | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires on personal characteristics, stress, anxiety and the relationship with electrial pain detection and tolerance thresholds. | — |
Countries
Netherlands
Outcome results
None listed