Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.

NCT02364856 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2026-04-17

No results posted yet for this study

Summary

This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).

Conditions

  • Cerebral Palsy
  • Pain
  • Children

Interventions

DEVICE

Analgesia Nociception Index

The Analgesia Nociception Index (ANI, MDoloris Medical Systems, Lille, France), based on Heart Rate Variability analysis, measures continuously and non-invasively the influence of Respiratory Sinus Arrhythmia on the heart rate. This 0-100 index indicates the proportion of paraS over sympathetic activity. In adults during surgery under general anesthesia, ANI decreases after painful stimulation and has been related to the balance between analgesia and nociception. ANI is calculated from heart rate recording.

Sponsors & Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK
  • Fondation Motrice

    collaborator OTHER
  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Justine AVEZ-COUTURIER, MD · University Hospital, Lille

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-24
Primary Completion
2018-04-12
Completion
2018-04-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364856 on ClinicalTrials.gov