Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia

Not Applicable

Recruiting

• Conditions: Chronic Insomnia Disorder
• Interventions: Device: Plasma therapy equipment; Device: Fake therapeutic device

• Registration Number: NCT06252779
• Lead Sponsor: Qinying Ma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-01-19
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18-75 years old, gender is not limited;
2. right-handed;
3. the audiovisual level is sufficient to complete the examinations required for the study;
4. No medication for 1 month before enrollment, or stable taking sleep-improving drugs but poor treatment effect;
5. Informed consent signed by the patient or family member.

Exclusion Criteria

1. Substance abuse/dependence within 6 months prior to enrollment;
2. Have had other mental illnesses within 6 months prior to enrollment;
3. Those with severe or unstable organic diseases;
4. pregnant or lactating women;
5. Those with a score of 3 (suicide) in 17 items of the Hamilton Depression Rating Scale ≥ 3;
6. Those who have participated in any other clinical trials within 1 month before enrollment;
7. In the opinion of the investigator, there is a situation that is not suitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Plasma stimulation therapy group	Plasma therapy equipment	-
False stimulation treatment group	Fake therapeutic device	-

Primary Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging	Before and after 14 day/false stimulation, 20 minutes each time	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.
Transcranial Magnetic Stimulation Combined Electroencephalography	Before and after 14 day/false stimulation, 20 minutes each time	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

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index Scale	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	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
Somatization Symptom Self Rating Scale	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	This scale can effectively assist non psychotherapists in identifying physical symptom disorders in a timely and early manner
Hamilton Anxiety Scale	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	Neurological examination scale for evaluating the anxiety status of subjects in the past month
Insomnia Severity Index Scale	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	ISI includes 7 questions that assess the severity and impact of insomnia, as well as its impact on daily function and psychological state.
Hamilton Depression Scale	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	Neurological examination scale for evaluating the depression status of subjects in the past month

Trial Locations

Locations (1)

Qinying Ma; 🇨🇳 Shijiazhuang, China