Hot baths tested as seizure treatment for rare childhood disorder
NCT ID NCT07602205
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking a daily hot bath (40-42°C for 20 minutes) at home can reduce epileptic seizures in children with CDKL5 deficiency disorder. The trial will include 34 children aged 6 months to 14 years whose seizures are not controlled by medication. Researchers will measure how many participants have at least a 50% drop in seizure frequency over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hot water baths (40-42°C for 20 minutes daily)
- What this could lead to
- If it works, this could offer a simple, drug-free way to reduce seizures in children with CDKL5 deficiency disorder.
- What could go wrong
- This is a very small early trial with only 34 participants. The treatment is unproven, and hot baths may not reduce seizures or could cause discomfort or safety risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures. 2. Male or female participants aged 6 months to 14 years, inclusive. 3. Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs). 4. At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening. 5. 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. 6. 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: 1. The VNS device has been in place for at least one year prior to the screening visit; 2. The stimulation parameters remain unchanged throughout the duration of the trial. 7. Parents or caregivers must be able and willing to maintain an accurate and comprehensive daily electronic seizure diary throughout the duration of the study. 8. Participants' legal guardians willing to provide written informed consent. Exclusion Criteria: 1. Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes. 2. Participants with skin ulceration or dermatologic conditions that make bathing unsuitable. 3. Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths. 4. A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths. 5. Patients who presented any clinical condition that in the opinion of the principal investigator made the patient not suitable to participate in the survey.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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