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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Stress, Psychological Sleep Initiation and Maintenance Disorders Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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active Transcranial Magnetic Stimulation

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

Group Type ACTIVE_COMPARATOR

active Transcranial Magnetic Stimulation

Intervention Type 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.

sham Transcranial Magnetic Stimulation

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

Group Type PLACEBO_COMPARATOR

sham Transcranial Magnetic Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No