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

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

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

Treatments: Device: active Transcranial Magnetic Stimulation; Device: sham Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06653959

KY20242082

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

active Transcranial Magnetic Stimulation

Active Comparator group

Description:

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

Treatment:

Device: active Transcranial Magnetic Stimulation

sham Transcranial Magnetic Stimulation

Placebo Comparator group

Description:

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

Treatment:

Device: sham Transcranial Magnetic Stimulation