Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A PROBE Clinical Trial

Prior treatment

• Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes.

Other illness

• Participants with skin ulceration or dermatologic conditions that make bathing unsuitable.
• A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths.
• Patients who presented any clinical condition that in the opinion of the principal investigator made the patient not suitable to participate in the survey.

Other

• Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths.

• A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures.
• Male or female participants aged 6 months to 14 years, inclusive.
• Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs).
• At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening.
• Treatment regimens of 0-4 ASMs were required to be stable for at least 4 weeks before screening and throughout the intervention. Ongoing ketogenic diets were allowed if remain unchanged during screening and treatment.
• Subjects who have undergone surgical implantation of vagus nerve stimulation (VNS) will be eligible for inclusion in the study, provided they meet all of the following criteria:
  • The VNS device has been in place for at least one year prior to the screening visit;
  • The stimulation parameters remain unchanged throughout the duration of the trial.
• Parents or caregivers must be able and willing to maintain an accurate and comprehensive daily electronic seizure diary throughout the duration of the study.
• Participants' legal guardians willing to provide written informed consent.