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Completed

NCT Number: NCT02364856

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

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).

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro, Lille, France

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About this study

Cerebral Palsy (CP) is the most common cause of motor handicap in childhood. CP is caused by damage to the developing brain, resulting in limits in movement, posture, or communication ability. CP affects about one newborn on 450. Pain management is one of the major expectations of CP patients (La Foundation Motrice, 2009) but in this population, pain is not recognized and inadequately treated.

Autonomic nervous system (ANS) is the automatic part of our nervous system regulating vital functions like cardiac beats or respiration. It is divided in sympathetic and parasympathetic. Analysis of heart rate variability (HRV) allows isolation of variations due to parasympathetic and their study. Works from the CIC-IT 807 lead to creation of an index called ANI (Analgesia Nociception Index), which is very sensitive to pain. It is validated on adults (Jeanne, 2012). It could be helpful to assess pain in CP, particularly in patients with communication disabilities. It is important to study this new tool in CP children before developing clinical applications.

Main objective of this study is to demonstrate that ANI is relevant in CP children and that it is sensitive to pain like in adults. Population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres. Duration of the study is 2 years. Parent's consent should be obtained. Investigators will record heart rate of children in 3 conditions in their rehabilitation centres: usual position, acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy). Parameters will be calculated in CIC-IT 807 lab (heart rate, ANI). Values of ANI and heart rate before and after painful stimulations will be compared. Correlation between ANI and results of usual pain assessment tools (rFLACC scale, visual analog scale) or characteristics of the population will be analyzed.

Lille University Hospital and CIC-IT 807 lab will collaborate with 2 pediatric rehabilitation centers: Centre Marc Sautelet and Zuydcoote Hospital.

Expected result is that ANI is relevant to CP children. Clinical applications are multiple: pain assessment, adaptation of medical equipment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cerebral Palsy
  • Rehabilitation care with physiotherapy and/or toxinum botulinum injections
  • Absence of identified autonomic nervous system disease
  • Parental and children (if applicable) consent obtained
  • French National Health System cover

Exclusion criteria

  • baseline Respiratory Frequency > 30/min
  • beta-blockers or atropinic treatment
  • Pacemaker, cardiac rhythm disease
  • Diabetes mellitus

Treatment and study plan

Analgesia Nociception Index

Device

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.

Primary outcomes

  1. Analgesia Nociception Index ANI before and after painful stimulation

    Time frame: 300 seconds before and 300 seconds after painful stimulation

    ANI is calculated from heart rate recordings 300 seconds before and after painful stimulations and compared

Secondary outcomes

  1. ANI at baseline

    Time frame: 300 seconds at rest

    ANI calculated from Heart rate recordings during 300 seconds in patient's usual position

  2. time for recovering

    Time frame: 10 minutes after painful stimulation

    time for recovering baseline ANI after painful stimulation

  3. pain score measured by Visual Analog Scale

    Time frame: immediately after painful stimulation

    when VAS will be applicable, children will be asked to score their pain with VAS scale; results of pain ratings with VAS will be compared to ANI results

  4. pain score measured by rFLACC scale

    Time frame: immediately after painful stimulation

    rFLACC scale will be scored immediately after painful stimulation; results of pain ratings with rFLACC will be compared to ANI results

  5. dysautonomic symptoms

    Time frame: inclusion

    results of ANI measures will be compared between two groups according to presence or absence of dysautonomic symptoms

  6. Gross Motor Function Classification System

    Time frame: inclusion

    results of ANI measures will be compared to the severity of motor impairment through the Gross Motor Function Classification System

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network
  • Fondation Motrice

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2015
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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