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

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 July 2023 to July 2024, and a total of 40 patients are planned to be included in the study.

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia Disorder
• Intervention / Treatment: Device: Plasma therapy equipment; Device: Fake therapeutic device

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinying Ma; Phone Number: 18633889488; Email: qinyingma1921@hebmu.edu.cn

Study Locations

• China
  • Shijiazhuang, China
    • Recruiting
    • Qinying Ma
    • Contact: Qinying Ma; Phone Number: 18633889488; Email: qinyingma1921@hebmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Clinical diagnosis of chronic insomnia;
2. The audio-visual level is sufficient to complete the necessary examinations for the research;
3. Not receiving medication treatment one month before enrollment, or stable use of antidepressants with poor treatment effect;
4. The patient or family member signs an informed consent form.

Exclusion Criteria:

1. Individuals who have substance abuse/dependence within the 6 months prior to enrollment;
2. Have suffered from other mental illnesses within the 6 months prior to enrollment; 3.Individuals with severe or unstable organic diseases;

4.Pregnant or lactating women; 5.Individuals with a score of ≥ 3 on item 3 (suicide item) in the 17 items of the Hamilton Depression Scale; 6.Individuals who have participated in any other clinical trials within the first month prior to enrollment; 7.The researchers believe that there are situations where it is not appropriate to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plasma stimulation therapy group	Device: Plasma therapy equipment; 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.
Placebo Comparator: False stimulation treatment group	Device: Fake therapeutic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Qinying Ma

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 20221117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No