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Tests treatment safety and results for Neuroimmune Diseases With Insomnia
Official title Study on the Clinical Efficacy of Transcranial Strong Alternating Current (Hi-tACS) in Patients With Neuroimmune Diseases With Insomnia
ClinicalTrials.gov ID: NCT07558616
What this study is testing
- What it's testing
- This study aims to comprehensively evaluate the therapeutic effects of high-intensity transcranial alternating current stimulation (hi-tACS) on insomnia symptoms in patients with idiopathic inflammatory demyelinating disorders (IIDDs) by analyzing both the overall disease characteristics of IIDDs and individual patient variability. Additionally, the study will investigate the neuroimmunomodulatory mechanisms of hi-tACS.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients with idiopathic inflammatory demyelinating disorders (IIDDs) meeting the diagnostic criteria, including neuromyelitis optica spectrum...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.