VR-PainCart pilot

Recruiting

Conditions: Pain

Registration Number: NL-OMON28178

Lead Sponsor: Centre for Human Drug Research

Brief Summary: .A.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

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

• 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;

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Electrical Stair: PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mAmm).<br>• Electrical Stair (including virtual reality simulation without enhancement): PDT (mA), PTT (mA), Area Under the VAS pain Curve<br>(AUC) (mAmm).<br>• Electrical Stair (including virtual reality simulation with enhancement): PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm).

Secondary Outcome Measures