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Evaluation and mechanism of repetitive transcranial magnetic stimulation and transcranial alternating current stimulation in the treatment of insomnia disorder

Evaluation and mechanism of repetitive transcranial magnetic stimulation and transcranial alternating current stimulation in the treatment of insomnia disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094291
Enrollment
Unknown
Registered
2024-12-19
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder

Interventions

active rTMS group:The left dorsolateral prefrontal lobe (DPLFC) was targeted as the stimulation target according to the 3-cm rule, and the stimulation frequency was 1Hz for 30 minutes a day, 5 days a
sham rTMS group:The left dorsolateral prefrontal lobe (DPLFC) was targeted as the stimulation target according to the 3-cm rule, and the stimulation frequency was 1Hz for 30 minutes a day, 5 days a we
fixed frequency tACS group:The central electrode was set as F3 and the surrounding electrode as F1,FC3,F5,AF3. The current intensity was 2mA and the immobilized stimulation frequency was 5Hz. The stim
personalized frequency tACS group:The central electrode was set as F3, and the surrounding electrodes as F1,FC3,F5, and AF3. The current intensity was 2mA. The personalized stimulation frequency was t
sham tACS group:Using the sham button built into the tACS device, the sham treatment will give the stimulation 30 seconds after the start of each stimulation and 30 seconds before the end of each stim
Healthy controls:None

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patient group inclusion criteria (only those who meet all of the following criteria can be enrolled) : 1.1. Aged 18-80 years old; 1.2. Right-handed; 1.3. meet the diagnostic criteria for insomnia disorder in the DSM-5; A. The chief complaint is dissatisfaction with the length or quality of sleep, accompanied by one (or more) of the following related symptoms: 1. Difficulty falling asleep; 2. Difficulty maintaining sleep, which is characterized by frequent awakenings or difficulty falling back to sleep after waking up; 3. Wake up early and can't fall back asleep; B. Sleep disturbances cause clinically significant distress or impairment of social, occupational, educational, learning, behavioral, or other important functions; C. Difficulty sleeping at least 3 nights per week; D. Difficulty sleeping for at least 3 months; E. Difficulty sleeping despite adequate sleep opportunities; F. Insomnia is not better explained by another sleep-wake disorder, nor does it occur only in the course of another sleep-wake disorder; G. Insomnia cannot be attributed to the physiological effects of a substance (e.g., abused drugs, medications); H. Co-existing mental and physical disorders do not adequately explain the insomnia complaint; 1.4.PSQI total score >5,ISI score >8; 1.5. Do not take benzodiazepine and non-benzodiazepine hypnotic drugs at least 2 weeks before the start of the experiment; 1.6. Consent to birth control during the study period (for female patients aged 18-50 years); 1.7. Agree not to receive benzodiazepine and non-benzodiazepine hypnotic drugs or other physical therapy to improve sleep (transcranial direct current, transcranial light regulation, etc.) throughout the trial period; 1.8. Obtain the informed consent signed by the patient, and the compliance is good; 2. Inclusion criteria of control group: 2.1. Aged 18-80 years old; 2.2. No symptoms or history of mental disorders and sleep disorders; 2.3. Total score of PSQI is less than or equal to 5; 2.4. Have not taken psychotropic drugs or hypnotic drugs; 2.5. Sign informed consent;

Exclusion criteria

Exclusion criteria: (a) suffering from a serious medical disease; 3.2 Patients with schizophrenia, schizoaffective disorder, persistent delusional disorder (paranoid psychosis), bipolar disorder, mental disorders caused by epilepsy, mental disorders accompanied by mental retardation, organic mental disorders; 3.3. Patients with major depressive disorder and suicidal tendencies; 3.4. Patients suffering from sleep disorders other than insomnia disorders (such as sleep apnea, restless leg syndrome, etc.); 3.5. Patients with frequent jet lag; 3.6. Patients with BMI>30; 3.4. Patients who have received physical therapy such as electroshock, transcranial magnetic stimulation or transcranial electrical stimulation within the last 3 months; 3.5. Patients with cochlear implants, cardiac pacemakers, or metal implants in the brain; 3.6. Have a history of epilepsy.

Design outcomes

Primary

MeasureTime frame
Resting-state electroencephalogram (EEG);polysomnography (PSG);Multimodal MRI scanning;Pittsburgh Sleep Quality Index;Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Beck Depression Inventory;Beck Anxiety Inventory;Mini-Mental State Examination;Montreal Cognitive Assessment Scale;

Countries

China

Contacts

Public ContactYuan Kai; Zhao Xumeng

School of Life Science and Technology, Xidian University; The Second Hospital of Hebei Medical University

kyuan@xidian.edu.cn+86 180 6689 8052

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026