Clinical trial NCT06653959: Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress, Psychological
Sleep Initiation and Maintenance Disorders
Transcranial Magnetic Stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment
timeFrame: Baseline and treatment day 5
Secondary outcomes:
measure: Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to treatment day 5
timeFrame: Baseline and treatment day 5
measure: Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5
timeFrame: Baseline and treatment day 5
measure: Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score
timeFrame: Baseline and treatment day 5
measure: Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score
timeFrame: Baseline and treatment day 5
measure: 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
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
Other outcomes:
Locations:
city: Xian
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Min Cai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.