Could a zappy headband cure insomnia in MS patients?
NCT ID NCT07558616
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a device that sends mild electrical currents to the brain (hi-tACS) can improve sleep in people with neuroimmune diseases like multiple sclerosis who also have insomnia. Eighty participants will receive 20 sessions of the stimulation or a sham treatment. The goal is to see if it helps them fall asleep and stay asleep better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-intensity transcranial alternating current stimulation (hi-tACS) device
- What this could lead to
- If it works, this could offer a non-drug option to help people with neuroimmune diseases sleep better.
- What could go wrong
- This is a small, early-stage study with only 80 participants, so results may not apply to everyone. The treatment is also time-intensive (20 sessions) and may not work for all.
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 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 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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18 to 65 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. Patients with idiopathic inflammatory demyelinating disorders (IIDDs) meeting the diagnostic criteria, including neuromyelitis optica spectrum disorders (NMOSD) \[based on the Chinese Guidelines for Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (2016 Edition)\] and multiple sclerosis (MS) \[based on the Chinese Guidelines for Diagnosis and Treatment of Multiple Sclerosis (2023 Edition)\], and accompanied by insomnia. * Aged between 18 and 65 years, regardless of gender. * Experiencing difficulty falling asleep, difficulty maintaining sleep, or early morning awakening on at least 3 nights per week for more than 3 months. * Severe daytime functional impairment (Chinese version of the Pittsburgh Sleep Quality Index, item 7 \[daytime dysfunction\] ≥2). * Having not taken hypnotics or insomnia treatment medication for at least 4 months. * Female participants aged 18-50 years who agree to use effective contraception throughout the study period. * Agreeing to refrain from receiving medication or other non-pharmacological treatments during the study period. * Agree to participate and sign the informed consent. 2. Patients diagnosed with chronic primary insomnia according to 《The Diagnostic and Statistical Manual of Mental Disorders》(Text Revision) (DSM-IV-TR) or 《International Classification of Diseases Tenth Revision》(ICD-10): * Aged between 18 and 65 years, regardless of gender. * Experiencing difficulty falling asleep, difficulty maintaining sleep, or early morning awakening on at least 3 nights per week for more than 3 months. * Severe daytime functional impairment (Chinese version of the Pittsburgh Sleep Quality Index, item 7 \[daytime dysfunction\] ≥2). * Having not taken hypnotics or insomnia treatment medication for at least 4 months. * Female aged 18\~50 years agreeing to adopt birth control measures during the study period. * Agreeing to refrain from receiving medication or other non-pharmacological treatments during the study period. * Agree to participate and sign the informed consent. Exclusion Criteria: * History of relapse within the past 1 month. * Drug adjustment within the past 1 month, or receipt of modified electroconvulsive therapy, transcranial magnetic stimulation therapy, or other neuralcontroltechnology therapy. * Participation in any other clinical studies within 1 month prior to enrollment or currently. * Presence of cochlear implant system, cardiac-pacemaker, or intracerebral implanted stimulators. * Impaired skin integrity at the electrode placement site, or allergy to electrode gel or adhesive. * History of organic brain diseases such as epilepsy, hydrocephalus, tumor of central nervous system, craniocerebral injury, or intracranial infection. * Pregnant or lactating women, or those intending pregnancy soon; * A score of ≥3 on the suicide item of the Hamilton Depression Scale, or coexisting severe mental disorders; * Presence of severe or unstable organic diseases; * Work night shifts; * Presence of other sleep disorders; * Poor patient compliance preventing cooperation with treatment, follow-up, or clinical, electroencephalographic (EEG), or imaging data collection; * Other circumstances deemed by the investigator as inappropriate for study participation.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China
RECRUITINGBeijing, Beijing Municipality, China
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