Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders

Not Applicable

Not yet recruiting

• Conditions: Stress, Psychological; Sleep Initiation and Maintenance Disorders; Transcranial Magnetic Stimulation

• Registration Number: NCT06653959
• Lead Sponsor: Xijing Hospital

Brief Summary

This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation

Detailed Description

This is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. They will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Study Start: 2024-11-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Be between the ages of 18 and 60 (both 18 and 60) and of any gender;
2. Experienced a severe traumatic event;
3. Stanford Acute Stress Reaction Questionnaire (SASRQ) ≥40 points;
4. PSQI > 7 points;
5. Good compliance and willingness to undergo this therapy.

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Exclusion Criteria

1. Sleep disorders that can be explained by a primary illness;
2. Concurrent psychotherapy;
3. Those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy;
4. Combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment	Baseline and treatment day 5	The Pittsburgh Sleep Quality Index, compiled in 1989 by Dr. Buysse, a psychiatrist at the University of Pittsburgh, and others. It is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 5 Score -Baseline Score).

Secondary Outcome Measures

Name	Time	Method
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to treatment day 5	Baseline and treatment day 5	Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 .; Change = (treatment day 5 Score -Baseline Score).
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5	Baseline and treatment day 5	The Stanford Acute Stress Reaction Questionnaire (SASRQ) is a commonly used international instrument for assessing acute stress disorders. It consists of 5 dimensions, including alertness, dissociation, avoidance, re-experiencing, and impairment of social functioning, with a total of 30 items, ranging from "not experiencing" to "always experiencing". A total of 30 items, ranging from "no experience" to "always experience", were assigned a score of 0 to 5, with a total score of 0 to 150. The higher the total score, the more severe the acute stress disorder, with a score of ≥40 suggesting a moderate likelihood of acute stress disorder.; Change = (treatment day 5 Score -Baseline Score).
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score	Baseline and treatment day 5	Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.; Change = (treatment day 5 Score -Baseline Score).
Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score	Baseline and treatment day 5	Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.; Change = (treatment day 5 Score -Baseline Score).
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 28 days after the end of treatment	Baseline and 28 days after the end of treatment	Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 .; Change = (28 days after the end of treatment Score -Baseline Score).
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 28 days after the end of treatment	Baseline and 28 days after the end of treatment	The Stanford Acute Stress Reaction Questionnaire (SASRQ) is a commonly used international instrument for assessing acute stress disorders. It consists of 5 dimensions, including alertness, dissociation, avoidance, re-experiencing, and impairment of social functioning, with a total of 30 items, ranging from "not experiencing" to "always experiencing". A total of 30 items, ranging from "no experience" to "always experience", were assigned a score of 0 to 5, with a total score of 0 to 150. The higher the total score, the more severe the acute stress disorder, with a score of ≥40 suggesting a moderate likelihood of acute stress disorder.; Change = (28 days after the end of treatment Score -Baseline Score).
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment	Baseline and 28 days after the end of treatment	Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.; Change = (28 days after the end of treatment Score -Baseline Score).
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment	Baseline and 28 days after the end of treatment	Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xian, Shaanxi, China