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

NCT07602205 | Not Yet Recruiting DMC

• 1 other identifier: 2026-161-001
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.

Conditions

CDKL5 Deficiency Disorder

Keywords

CDKL5 Deficiency Disorder; fever; epilepsy; home-based hyperthermic baths; genotype-phenotype

Outcome Measures

Primary Outcomes (1)

• Seizure Responder Rate

  The proportion of participants achieving at least a 50% reduction in seizure frequency from baseline during the 12-week home-based hyperthermic baths period.

  Baseline to week 12 at home-based hyperthermic baths phase

Secondary Outcomes (2)

• Change in Seizure Frequency

  Baseline to week 12 at home-based hyperthermic baths phase

• Seizure-free Days

  Baseline to week 12 at home-based hyperthermic baths phase

Study Arms (2)

Home-based hyperthermic baths group

EXPERIMENTAL

Patients with CDKL5 deficiency disorder assigned to the daily home-based hyperthermic bathing group will undergo immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision.

Behavioral: Home-based hyperthermic Baths

Control Group

NO INTERVENTION

Participants assigned to the control group will not receive hyperthermic baths during the study period and will continue their usual care, including their existing antiseizure treatment regimen. Seizure frequency and safety outcomes will be assessed according to the study protocol.

Interventions

Home-based hyperthermic Baths BEHAVIORAL

A 12-week daily home-based hyperthermic bathing intervention consisting of immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. The intervention will be administered according to the study protocol.

Home-based hyperthermic baths group

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes.
• Participants with skin ulceration or dermatologic conditions that make bathing unsuitable.
• Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths.
• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

CDKL5 deficiency disorder; Fever; Epilepsy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liankun Ren, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD, PhD

CONTACT

+86 13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants, caregivers, and investigators will not be masked to treatment allocation. However, outcome assessors who evaluate seizure outcomes will be masked to group assignment. This trial therefore uses an open-label, blinded-endpoint design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share