Using hyperthermic baths to treat seizures in children with CDKL5 deficiency

Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in Children With CDKL5 Deficiency: A Single-center, Self Control Trial

This study is testing if warm baths can help reduce seizures in young children with CDKL5 deficiency who have trouble controlling their seizures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 6 Months to 6 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06447675 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of hyperthermic baths as an adjunctive therapy for reducing seizure frequency in children diagnosed with CDKL5 deficiency. It is a single-center, preliminary feasibility clinical trial that aims to include 8 participants aged 6 months to less than 6 years who have refractory seizures. The study will assess the impact of hyperthermic baths on seizure control in this specific patient population, potentially offering new therapeutic options for those with limited treatment success.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to less than 6 years with a confirmed diagnosis of CDKL5 deficiency and refractory seizures.

Not a fit: Patients who do not have CDKL5 deficiency or those whose seizures are well-controlled with existing treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for children suffering from drug-resistant epilepsy due to CDKL5 deficiency.

How similar studies have performed: While the use of hyperthermic baths is a novel approach in this context, similar studies exploring alternative therapies for drug-resistant epilepsy have shown promise.

Eligibility criteria

Inclusion Criteria:

* A diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures
* Male or female participants aged 6 months to less than 6 years
* Parent(s) or LAR willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures
* Failure to control seizures despite appropriate trial of 1 or more anti-seizure medications at therapeutic doses
* Have a history of at least 16 countable seizures per 4 weeks during the 8 weeks prior to screening. Countable seizures will be defined by the following:Seizures with or without impairment of consciousness with a clear motor component, including generalized tonic-clonic, focal to bilateral tonic-clonic, atonic, bilateral clonic, bilateral tonic, focal motor seizures with or without impaired awareness, or infantile spasms. Clusters of infantile spasms/tonic seizures will be counted as a single seizure.
* Participants should be on a stable regimen of anti-seizure medications for ≥ 4 weeks prior to the screening visit, without a foreseeable change in dosing for the duration of the DB phase.
* Vagus nerve stimulator (VNS) are permitted, but should be implanted for 1 year prior to screening and settings should be unchanged throughout the study.
* Parent/caregiver is able and willing to maintain an accurate and complete daily seizure eDiary for the duration of the study.

Exclusion Criteria:

* Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
* Tissue damage (eczema, etc.) in the area where hyperthermic baths will be applied on the skin.
* Seizures associated with hyperthermic baths.
* Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital,Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Liankun Ren, MD — Xuanwu Hospital, Beijing
• Study coordinator: Liankun Ren, MD

Conditions CDKL5 Deficiency Disorder; Hyperthermic Baths; Drug Resistant Epilepsy; CDKL5