CNS Testing

Biotrial Core Lab provides a CNS testing battery to clinical sites, adapted to the trial needs.

Biotrial’s test battery encompasses various components that facilitate the measurement of:

  • Memory
  • Attention
  • Vigilance
  • Balance
  • Oculography
  • Subjective elements

Our tools are designed to be flexible and can seamlessly integrate sponsor-specific tests & questionnaires.

Biotrial-Corelab-Cns-Testing

The CNS tests used by Biotrial enable the sponsors to gather pertinent Pharmacodynamic (PD) data. Often these data complete the clinical observations made by site staff and provide deeper insight into drug effects.

Pepsy Cognitive Testing

Biotrial Core Lab Psychomotorperformance

PEPSY Services

  • Consulting – Protocol Design & Test Selection
  • Equipment Shipment & Installation Worldwide
  • Project Management
  • Staff Training
  • 24/7 Support Hotline
  • Data Collection & Continuous Quality Monitoring
  • Data Management & Transfer
  • Statistical Analysis & Expert Report

PEPSY Software Features

  • Validated and compliant with all regulatory requirements (CFR 21 Part 11)
  • User-friendly interface, approved by Biotech companies and Big Pharma
  • Adapted to any type of studies from Phase I to Phase IV
  • Cost effective
  • Adaptable to new tests & questionnaires
  • Available and validated in the following languages: English, French, German, Italian, Spanish and Japanese

Body Sway – Posturography

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Using a dedicated platform, we implement posturography which is an objective, sensitive, reliable and non-invasive method designed to assess the effects of drugs on body sway and vigilance.

This can be particularly beneficial in trials where an effect is anticipated on these elements, or in alcohol interaction studies where it provides a highly robust endpoint.

Oculography measures

Various methods can be set up to measure oculography endpoints which can include:

  • Saccadic Eye Movement
  • Smooth Pursuit
  • Fixation
  • Nystagmus
  • Pupillometry
  • Eye-tracking

Different devices, adapted to the requirements indicated for each endpoint, can be used.

For eye-tracking endpoints, where we look to identify which areas of interest are observed by the participant, simple eye-trackers with sampling frequencies of 60-80Hz can be used, however when investigating SEM, Pursuit or Nystagmus, high-frequency sampling is required, and adapted hardware must be used.

Attention & Psychomotor Performance

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Simple Reaction Time (SRT)

  • Motor response to a simple visual stimulus

Choice Reaction time (CRT)

  • Motor response to a complex visual stimulus

Tracking test (TT)

  • Hand-eye coordination and delays in visual motor response

Rapid Visual Information Processing (RVIP)

  • Sustained attention and working memory

Digit Vigilance (DV)

  • Sustained attention

Divided Attention (DA)

  • Capacity to divide and allocate attention

Body Sway (BS)

  • Effects of drug on body sway and vigilance, recorded using a force-platform

Saccadic Eye Movement (SEM)

  • Analysis of eye-movement to detect changes in attention and sedation

Memory

Biotrial Core Lab Memory

Learning memory task (LMT)

  • Short and long-term memory

Numeric Working Memory (NWM)

  • Working memory assessment 

Spatial Working Memory (SWM)

  • Working memory assessment 

Subjective Evaluations

  • Bond & Lader VAS
  • Addiction Research Center Inventory (ARCI)
  • Leeds Sleep Evaluation Questionnaire (LSEQ)
  • Profile Of Mood Scale (POMS)
  • Discontinuation Emergent Signs & Symptoms (DESS)
  • Pain VAS
  • Columbia Suicide Severity Scale (C-SSRS)
  • Appetite and Satiety VAS
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