Clinical trial NCT06252779: Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
Official title: Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia Disorder
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional magnetic resonance imaging
timeFrame: Before and after 14 day/false stimulation, 20 minutes each time
measure: Transcranial Magnetic Stimulation Combined Electroencephalography
timeFrame: Before and after 14 day/false stimulation, 20 minutes each time
Secondary outcomes:
measure: Insomnia Severity Index Scale
timeFrame: 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
measure: Pittsburgh Sleep Quality Index Scale
timeFrame: 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
measure: Hamilton Anxiety Scale
timeFrame: 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
measure: Hamilton Depression Scale
timeFrame: 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
measure: Somatization Symptom Self Rating Scale
timeFrame: 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
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Qinying Ma
Study officials:
References: