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

NCT06252779 | Recruiting

• 1 other identifier: 20221117
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Plasma stimulation therapy group

EXPERIMENTAL

Device: Plasma therapy equipment

False stimulation treatment group

PLACEBO COMPARATOR

Device: Fake therapeutic device

Interventions

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.

Plasma stimulation therapy group

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.

False stimulation treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qinying Ma: lead

Study Sites (1)

Qinying Ma

Shijiazhuang, China

RECRUITING

Central Study Contacts

Qinying Ma

CONTACT

18633889488; qinyingma1921@hebmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 12, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-02

Locations

CN (1)