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

Last updated: December 30, 2024
Sponsor: Qinying Ma
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Fake therapeutic device

Plasma therapy equipment

Clinical Study ID

NCT06252779
20221117
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 thestudy;

  4. No medication for 1 month before enrollment, or stable taking sleep-improving drugsbut poor treatment effect;

  5. Informed consent signed by the patient or family member.

Exclusion

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 RatingScale ≥ 3;

  6. Those who have participated in any other clinical trials within 1 month beforeenrollment;

  7. In the opinion of the investigator, there is a situation that is not suitable toparticipate in this study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Fake therapeutic device
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Qinying Ma

    Shijiazhuang,
    China

    Active - Recruiting

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