Excessive Crying in Children With Cerebral Palsy and Communication Deficits

• Status: Completed
• Trial end date: 2020-08-04
• Target enrollment: 0
• Participant gender: All

Summary

Management of excessive crying in children with cerebral palsy and communication deficits [ECCCPCD] was guided by the associated clinical findings and investigations.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sathbhavana Brain Clinic
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Anticonvulsants; Baclofen; Clonazepam; Diazepam; Gabapentin; Lamotrigine; Tetrabenazine; Topiramate; Trihexyphenidyl

Criteria

1. A child with cerebral palsy under the age of 15 years and could not communicate the reason for excessive crying because of young age or global developmental delay/profound intellectual retardation.

2. Excessive crying of >7.5 hours daily for 30 consecutive days unresponsive to treatment by the pediatrician, orthopedic surgeon, gastroenterologist, and physiotherapist.

3. Minimum cry intensity for recording: If the intensity of crying was so high that the caregiver could not hear radio, TV, or another person talking to her [sitting near her], the cry duration was recorded.

4. History, clinical, and neuroimaging findings (structural MRI) were suggestive of chronic static encephalopathy.

5. Motor impairment could be explained by an insult that occurred in the developing fetal or infant brain.

Exclusion Criteria:

1. Medicines used in the study were used in the previous 30 days, and it was impossible to taper off the drugs without worsening of symptoms.

2. Excessive crying due to known causes.

3. Progressive encephalopathies.