Conceptio › Archive › ClinicalTrials.gov
ClinicalTrials.gov public full text Public Domain

Effect of Botulinum Toxin on Muscles of Children With Cerebral Palsy

Hospices Civils de Lyon · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
Open Source ↗
cerebral-palsyna
Cerebral palsy (CP) is a group of non-progressive motor dysfunction but often changing, secondary to injury or brain abnormalities that occur in early stages of development. In children with CP, the brain injury lead to a delayed motor development in the first weeks, associated with muscular spasticity. Drug treatments include oral treatments (baclofen and tizanidine) and injectable treatments like Botox (intramuscular injection) and neurolysis with alcohol or phenol (local injection into the nerve). Regarding botulinum toxin, there is no study questioning its effectiveness. However, no publication on the pathophysiology of human muscle of the CP child after toxin injection was found. The action of the toxin on the neuromuscular junction (NMJ) and muscle structure is unknown in children with CP. The primary objective of this study is to describe structural abnormalities of the CP child's muscle following multiple toxin injections in terms of NMJ fragmentation and axonal sprouting. Secondary objectives: To evaluate the relationship between: * The severity of the motor impairment and muscle structural abnormalities. * The clinical measure of spasticity and muscle structural abnormalities. * To compare the structure spastic muscles with toxin injections and spastic muscle without toxin injections For muscles with multiple toxin injections, assessing the relationship between : * The number of toxin injections and muscle structural abnormalities. * The date of the first injection and muscle structural abnormalities. * The total dose of injected toxin in the muscle and its structural abnormalities. * The nature of the product injected in the muscle and its structural abnormalities. This innovative study will improve the knowledge on the effects of long-term botulinum toxin injections on the muscle (and therefore its safety in usual care), on the spastic muscle NMJ of CP children, on the pathophysiology of the CP child's muscle. All the visits all acts will be per
Conceptio Open Archive

Analyze & explore related research in Conceptio

Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.

This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗

Related documents

Record · ID 1101181
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive