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

Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation Based on vlPFC-VTA Individualized Functional Connectivity Localization for the Treatment of Post-stress Sleep Disorders

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

Study Overview

• Status: Not yet recruiting
• Conditions: Transcranial Magnetic Stimulation; Stress, Psychological; Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Device: active Transcranial Magnetic Stimulation; Device: sham 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yaochi Zhang; Phone Number: 18294037117; Email: a18294037117@163.com

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710000
      • Xijing Hospital
      • Contact: zhao, PhD; Phone Number: 18792536506; Email: zhangyc_2022@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active Transcranial Magnetic Stimulation; The most relevant site of functional connectivity between vlPFC-VTA will be targeted for continuous theta burst stimulation	Device: active Transcranial Magnetic Stimulation; Based on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for stimulation for 5 consecutive days.
Placebo Comparator: sham Transcranial Magnetic Stimulation; The most relevant site of functional connectivity between vlPFC-VTA will be targeted for sham continuous theta burst stimulation	Device: sham Transcranial Magnetic Stimulation; Based on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for sham stimulation for 5 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment	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).	Baseline and treatment day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 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).	Baseline and treatment day 5
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 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).	Baseline and treatment day 5
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score	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).	Baseline and treatment day 5
Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score	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).	Baseline and treatment day 5
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	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).	Baseline and 28 days after the end of treatment
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 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).	Baseline and 28 days after the end of treatment
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 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).	Baseline and 28 days after the end of treatment
Change in Hamilton Anxiety Scale scores from baseline to 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.	Baseline and 28 days after the end of treatment

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Min Cai, PhD, Xijing Hospital

Publications and helpful links

General Publications

• Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
• Cai M, Zhu Y, Shanley MR, Morel C, Ku SM, Zhang H, Shen Y, Friedman AK, Han MH. HCN channel inhibitor induces ketamine-like rapid and sustained antidepressant effects in chronic social defeat stress model. Neurobiol Stress. 2023 Aug 19;26:100565. doi: 10.1016/j.ynstr.2023.100565. eCollection 2023 Sep.
• Luo YJ, Li YD, Wang L, Yang SR, Yuan XS, Wang J, Cherasse Y, Lazarus M, Chen JF, Qu WM, Huang ZL. Nucleus accumbens controls wakefulness by a subpopulation of neurons expressing dopamine D1 receptors. Nat Commun. 2018 Apr 20;9(1):1576. doi: 10.1038/s41467-018-03889-3.
• Blumberger DM, Maller JJ, Thomson L, Mulsant BH, Rajji TK, Maher M, Brown PE, Downar J, Vila-Rodriguez F, Fitzgerald PB, Daskalakis ZJ. Unilateral and bilateral MRI-targeted repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled study. J Psychiatry Neurosci. 2016 Jun;41(4):E58-66. doi: 10.1503/jpn.150265.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Stress, Psychological
• Other Study ID Numbers: KY20242082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No