Migraine with or without aura comorbid with insomnia disorder
Conditions
Interventions
Low-frequency electrical stimulation Group A:HeadaTerm transcutaneous electrical nerve stimulation (low-frequency, 1 Hz)
High-frequency electrical stimulation Group B (active control group):HeadaTerm transcutaneous electrical nerve stimulation (high-frequency, 1 Hz)
Sponsors
The First Hospital Of Jiaxing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age range: Aged between 18 and 65 years, regardless of gender. 2.Diagnostic criteria: Meet the diagnostic criteria for migraine (with or without aura) according to the International Classification of Headache; 3.Attack frequency: Have had at least 4 and no more than 8 migraine attacks per month on average over the past 3 months. 4.Sleep parameters: Pittsburgh Sleep Quality Index (PSQI) score = 8, or sleep onset latency = 30 minutes, or total sleep time < 6.5 hours. 5.Informed consent: Voluntarily participate in the trial, sign the written informed consent form, and be willing and able to comply with scheduled follow-up visits and complete all assessments.
Exclusion criteria
Exclusion criteria: 1.Contraindications to physical therapy: Intolerance to transcutaneous electrical nerve stimulation (e-TNS), or presence of absolute contraindications to electrical stimulation, including but not limited to implanted cardiac pacemakers, deep brain electrodes, or a history of epilepsy. 2.Concurrent medication use: Use of calcitonin gene-related peptide (CGRP) antagonists within the recent period, or adjustment or instability of prophylactic anti-migraine medication within the past 1 month. 3.Comorbid medical conditions: Presence of other severe primary diseases, such as severe hepatic or renal insufficiency, malignant tumors, severe cardiovascular diseases, or active autoimmune diseases. 4.Psychiatric status: History of substance abuse, alcohol dependence, or severe psychiatric disorders, including schizophrenia, major depressive disorder, severe anxiety disorder, or cognitive impairment. 5.Special populations: Pregnant or breastfeeding women, as well as women planning to become pregnant during the study period. 6.Participation in other trials: Participation in other clinical trials involving medical devices or pharmaceutical agents within 3 months prior to screening. 7.Adherence: Subjects who, in the judgment of the investigator, are unlikely to comply with scheduled follow-up visits, adhere strictly to the treatment protocol, or demonstrate adequate cooperation throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device usage;Insomnia Severity Index;Visual Analogue Scale;Pittsburgh Sleep Quality Index;Number of migraine attacks per 2-week period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale; | — |
Countries
China
Contacts
Public ContactChen Yue / Hu Jin
The First Hospital Of Jiaxing
Outcome results
None listed