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

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

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).

Study Overview

• Status: Completed
• Conditions: Pain; Cerebral Palsy; Children
• Intervention / Treatment: Device: Analgesia Nociception Index

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro
  • Villeneuve-d'Ascq, France, 59650
    • Centre de Réadaptation Fonctionnelle Marc Sautelet
  • Zuydcoote, France, 59123
    • Hôpital maritime de Zuydcoote, Service de SSR Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children with cerebral palsy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia Nociception Index ANI before and after painful stimulation	ANI is calculated from heart rate recordings 300 seconds before and after painful stimulations and compared	300 seconds before and 300 seconds after painful stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ANI at baseline	ANI calculated from Heart rate recordings during 300 seconds in patient's usual position	300 seconds at rest
time for recovering	time for recovering baseline ANI after painful stimulation	10 minutes after painful stimulation
pain score measured by Visual Analog Scale	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	immediately after painful stimulation
pain score measured by rFLACC scale	rFLACC scale will be scored immediately after painful stimulation; results of pain ratings with rFLACC will be compared to ANI results	immediately after painful stimulation
dysautonomic symptoms	results of ANI measures will be compared between two groups according to presence or absence of dysautonomic symptoms	inclusion
Gross Motor Function Classification System	results of ANI measures will be compared to the severity of motor impairment through the Gross Motor Function Classification System	inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Clinical Investigation Centre for Innovative Technology Network; Fondation Motrice
• Investigators: Principal Investigator: Justine AVEZ-COUTURIER, MD, University Hospital, Lille

Publications and helpful links

General Publications

• Jeanne M, Delecroix M, De Jonckheere J, Keribedj A, Logier R, Tavernier B. Variations of the analgesia nociception index during propofol anesthesia for total knee replacement. Clin J Pain. 2014 Dec;30(12):1084-8. doi: 10.1097/AJP.0000000000000083.
• Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.
• De Jonckheere J, Rakza T, Logier R, Jeanne M, Jounwaz R, Storme L. Heart rate variability analysis for newborn infants prolonged pain assessment. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7747-50. doi: 10.1109/IEMBS.2011.6091909.
• Faye PM, De Jonckheere J, Logier R, Kuissi E, Jeanne M, Rakza T, Storme L. Newborn infant pain assessment using heart rate variability analysis. Clin J Pain. 2010 Nov-Dec;26(9):777-82. doi: 10.1097/ajp.0b013e3181ed1058.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2015
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): April 12, 2018

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimated): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Pain; Autonomic Nervous System; Children
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Cerebral Palsy
• Other Study ID Numbers: 2013_22; 2014-A00583-44 (Other Identifier: ID RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No