Transcranial plasma stimulation for treating chronic insomnia
Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
This study is testing whether a new treatment called transcranial plasma stimulation can help people with chronic insomnia sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Hebei Medical University Academic / other |
| Locations | 1 site (Shijiazhuang) |
| Trial ID | NCT06252779 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcranial plasma stimulation in treating chronic insomnia disorder. Conducted at the First Hospital of Hebei Medical University, it aims to enroll 40 patients aged 18-75 who meet specific criteria. The study will assess various scales, including the Hamilton Anxiety Scale and Pittsburgh Sleep Quality Index, before and after the intervention. The research will utilize advanced imaging techniques like TMS-EEG and functional MRI to explore the underlying mechanisms of the treatment.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18-75 with chronic insomnia who have not responded well to sleep-improving medications.
Not a fit: Patients with severe mental illnesses, substance abuse issues, or unstable organic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being for patients suffering from chronic insomnia.
How similar studies have performed: While the approach of using plasma stimulation is relatively novel, similar studies using transcranial stimulation techniques have shown promising results in treating various neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shijiazhuang
- Qinying Ma — Shijiazhuang, China (Recruiting)
Study contacts
- Study coordinator: Qinying Ma
- Email: qinyingma1921@hebmu.edu.cn
- Phone: 18633889488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.