Ongoing Clinical Trials for Injury to Brachial Plexus Due to Birth Trauma
Currently, there is one ongoing clinical trial investigating treatments for injury to the brachial plexus due to birth trauma. This trial is exploring the use of Botulinum Toxin Type A (Botox) to prevent shoulder deformities in infants affected by this condition. The study is being conducted in France and focuses on early intervention to improve long-term shoulder function in affected children.
Clinical trial locations
Study on Botulinum Toxin Type A for Preventing Shoulder Deformity in Infants with Brachial Plexus Palsy
This clinical trial is investigating the use of Botulinum Toxin Type A, commonly known as Botox, as a preventive treatment for shoulder deformities in infants with Obstetrical Brachial Plexus Palsy. This condition occurs when nerve damage during birth affects the shoulder, arm, and hand, potentially leading to weakness, limited movement, and joint problems as the child grows.
Main focus and goal: The primary aim of this study is to determine whether early Botox injections can prevent the worsening of shoulder joint problems, specifically a condition called posterior glenohumeral joint subluxation, which is a partial dislocation of the shoulder joint. The trial compares infants who receive Botox injections with those who receive a placebo to assess the treatment’s effectiveness in maintaining better shoulder joint positioning and improving movement over time.
Inclusion criteria: To participate in this trial, infants must meet specific requirements:
- Both boys and girls with Obstetrical Brachial Plexus Palsy are eligible
- Age between 10 and 11 months at the time of enrollment
- The affected shoulder must show either a reduced ability to rotate outward by at least 10 degrees compared to the unaffected shoulder, or a score below 6 on the Active Movement Scale for certain movements
- Parents or guardians must provide consent for their child’s participation
Exclusion criteria: Infants cannot participate if they:
- Do not have Obstetrical Brachial Plexus Palsy
- Are not within the 11 to 18 months age range during the study period
- Have already received botulinum toxin treatment for their shoulder condition
- Have other medical conditions that might interfere with the study
- Have parents or guardians who do not agree to participate
How the trial works: At 12 months of age, eligible infants receive an intramuscular injection of Botulinum Toxin Type A into their shoulder muscles. The medication works by blocking the release of acetylcholine, a chemical that causes muscle contractions, thereby helping to relax the muscles and prevent the shoulder joint from moving out of place.
Throughout the study, infants undergo regular assessments including MRI scans to monitor changes in the shoulder joint and muscle condition. Follow-up evaluations occur over six months, with a final assessment at 18 months of age. Long-term monitoring continues as part of routine clinical practice up to 10 years of age to track the child’s development and any need for surgical interventions.
Investigational drug: Botulinum Toxin Type A is administered through injection and is being studied specifically for its potential to prevent shoulder deformity progression in young children with nerve injury from birth trauma.
Summary
Currently, only one clinical trial is actively recruiting participants for injury to the brachial plexus due to birth trauma. This trial is taking place in France and represents an important step in exploring early preventive treatments for shoulder complications in affected infants. The focus on Botulinum Toxin Type A reflects growing interest in using this medication beyond its traditional applications, specifically targeting muscle imbalance issues that can lead to joint deformities in young children with nerve injuries. The trial’s comprehensive approach, including long-term follow-up until age 10, demonstrates a commitment to understanding both immediate and lasting effects of this intervention.