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

NCT06653959 | Not Yet Recruiting DMC

• 1 other identifier: KY20242082
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5

  Baseline and treatment day 5

• Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score

  Baseline and treatment day 5

• Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 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

  Baseline and 28 days after the end of treatment

Study Arms (2)

active Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

The most relevant site of functional connectivity between vlPFC-VTA will be targeted for continuous theta burst stimulation

Device: active Transcranial Magnetic Stimulation

sham Transcranial Magnetic Stimulation

PLACEBO COMPARATOR

The most relevant site of functional connectivity between vlPFC-VTA will be targeted for sham continuous theta burst stimulation

Device: sham Transcranial Magnetic Stimulation

Interventions

active Transcranial Magnetic Stimulation DEVICE

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.

active Transcranial Magnetic Stimulation

sham Transcranial Magnetic Stimulation DEVICE

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.

sham Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

Related Publications (4)

• 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.

  PMID: 37664876 BACKGROUND

• 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.

  PMID: 29679009 BACKGROUND

• 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.

  PMID: 25192980 BACKGROUND

• 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.

  PMID: 27269205 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Min Cai, PhD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yaochi Zhang

CONTACT

18294037117; a18294037117@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)