NCT02364856

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 24, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2018

Completed
Last Updated

April 17, 2026

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

February 10, 2015

Last Update Submit

April 16, 2026

Conditions

Cerebral PalsyPainChildren

Keywords

Autonomic Nervous SystemCerebral PalsyPainChildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • ANI at baseline

    300 seconds at rest

  • time for recovering

    10 minutes after painful stimulation

  • pain score measured by Visual Analog Scale

    immediately after painful stimulation

  • pain score measured by rFLACC scale

    immediately after painful stimulation

  • dysautonomic symptoms

    inclusion

  • +1 more secondary outcomes

Study Arms (1)

Children with cerebral palsy

Device: Analgesia Nociception Index

Interventions

Analgesia Nociception IndexDEVICE

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.

Children with cerebral palsy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro

Lille, France

Location

Centre de Réadaptation Fonctionnelle Marc Sautelet

Villeneuve-d'Ascq, 59650, France

Location

Hôpital maritime de Zuydcoote, Service de SSR Enfant

Zuydcoote, 59123, France

Location

Related Publications (4)

  • 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.

    PMID: 24525906BACKGROUND

  • 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.

    PMID: 22454275BACKGROUND

  • 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.

    PMID: 22256134BACKGROUND

  • 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.

    PMID: 20973153BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyPain

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Justine AVEZ-COUTURIER, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

April 24, 2015

Primary Completion

April 12, 2018

Study Completion

April 12, 2018

Last Updated

April 17, 2026

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)