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This study is a single center study, led by Dr. Ma Qinying from the Department of Neurology at the First Hospital of Hebei Medical University. This study is an intervention study on plasma stimulation, involving patients with insomnia disorders to observe the effectiveness of plasma stimulation on insomnia disorders. Collect the Hamilton Anxiety Scale, Hamilton Depression Scale, Pittsburgh Sleep Quality Index Scale, Insomnia Severity Index Scale, and Somatization Symptom Self Rating Scale from patients before and after intervention. Transcranial magnetic stimulation synchronous electroencephalogram (TMS-EEG) and functional magnetic resonance imaging data. The research period is from December 2023 to July 2025, and a total of 40 patients are planned to be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma stimulation therapy group | Experimental |
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| False stimulation treatment group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma therapy equipment | Device | The host of this product contains a high-voltage generator that can generate high-voltage electrical energy and deliver it to the treatment head. The air supply mechanism sends air to the ionization chamber inside the treatment head, which is ionized under the action of high-voltage electricity to generate thermal plasma, forming a particle flow mainly composed of active nitric oxide (pNO), which is then sprayed out from the nozzle of the treatment head to the target tissue of the human body. PNO particles can alter skin permeability, allowing them to act on specific parts of the body after transdermal absorption on the surface of the body.The patient will receive 14 days of treatment, with 20 minutes per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional magnetic resonance imaging | Functional magnetic resonance imaging (fMRI) is an imaging technique based on blood oxygen level dependence (BOLD), which can display small changes in magnetic resonance signals caused by changes in blood oxygenation status in venous capillaries in various regions of the brain. | Before and after 14 day/false stimulation, 20 minutes each time |
| Transcranial Magnetic Stimulation Combined Electroencephalography | with the advancement of technology, magnetic compatible EEG electrodes and amplifiers have been invented, making it possible to synchronously record undisturbed EEG under transcranial magnetic stimulation. The monitoring technology of transcranial magnetic stimulation combined electroencephalography (TMS-EEG) has also emerged | Before and after 14 day/false stimulation, 20 minutes each time |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index Scale | ISI includes 7 questions that assess the severity and impact of insomnia, as well as its impact on daily function and psychological state. | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinying Ma | Contact | 18633889488 | qinyingma1921@hebmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qinying Ma | Recruiting | Shijiazhuang | China |
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| Fake therapeutic device | Device | False stimuli with the same appearance and pattern as Plasma therapy equipment.The patient will receive 14 days of treatment, with 20 minutes per day. |
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| Pittsburgh Sleep Quality Index Scale |
PSQI was developed by Pittsburgh psychiatrist Buysse in the United States to evaluate the sleep quality of participants in the past month. It is suitable for evaluating the sleep quality of patients with sleep disorders and mental disorders, as well as for evaluating the sleep quality of the general population |
| Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation |
| Hamilton Anxiety Scale | Neurological examination scale for evaluating the anxiety status of subjects in the past month | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation |
| Hamilton Depression Scale | Neurological examination scale for evaluating the depression status of subjects in the past month | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation |
| Somatization Symptom Self Rating Scale | This scale can effectively assist non psychotherapists in identifying physical symptom disorders in a timely and early manner | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation |