Efficacy of Repeated Transcranial Magnetic Stimulation Based on Near-infrared Imaging in Patients With Post-stroke Depression

Not Applicable

Completed

• Conditions: Stroke; Post-stroke Depression

• Registration Number: NCT06723769
• Lead Sponsor: Dingqun Bai

Brief Summary

This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).

Detailed Description

To evaluate the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) for the right dorsolateral prefrontal cortex (DLPFC) in patients with post-stroke depression (PSD), and explore the possible neural mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).

Patients were randomly assigned to the rTMS and control groups. the treatment effect was assessed by the Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI). Meanwhile, fNIRS was used to detect the changes of blood oxygen concentration in the frontal cortex.

After treatment, the score of the HAMD scale in the rTMS group decreased more significantly than in the control group (P\<0.05). The value of CH17 oxyhemoglobin (HBO) and the value of CH6 deoxyhemoglobin (HBR) were decreased after rTMS. The HbR of CH6 and CH8 decreased significantly, the HbR of CH12 and CH15 increased significantly (P\<0.05). The HAMA, NIHSS and Barthel scores improved more significantly in the rTMS group.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 1. Hospitalized patients over 18 years of age; (2) Meet the stroke diagnostic criteria of the Fourth National Conference on Cerebrovascular Diseases and have been confirmed as ischemic or hemorrhagic stroke by head CT and MRI; (3) Symptoms of PSD such as low mood, loss of interest in daily life, insomnia, or poor appetite persist for more than 1 week and meet the inclusion criteria of the DSM-5; (4) Hamilton Depression Scale score-17 (HAMD) > 7; (5) Stable vital signs, willing to accept the treatment method of this study, and sign the informed consent for treatment.

Exclusion Criteria

• (1) Patients with a history of mental disorders and depression before stroke onset; (2) Patients with consciousness disorder, severe aphasia or comprehension and expression disorder after stroke; (3) Patients with serious cognitive impairment can not cooperate with the psychological evaluator; (4) Patients with metal implants in the skull; (5) People with cardiac pacemakers; (6) Previous head trauma, alcoholism, or family history of epilepsy and another risk of seizures; (7) psychotic symptoms such as agitation, speech and behavior disorder; (8) refuse to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAMD-17)	pre and post 4 weeks treatment	evaluate the degree of depression
Functional near-infrared spectroscopy (fNIRS assessment)	pre and post 4 weeks treatment	measure brain function to determine the effect of rTMS on cerebral blood flow change

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale(HAMA)	pre and post 4 weeks treatment	evaluate the degree of anxiety
National Institutes of Health Stroke Scale(NIHSS)	pre and post 4 weeks treatment	evaluate the degree of neurological impairment
Barthel Index(BI)	pre and post 4 weeks treatment	evaluate the degree of daily living ability

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,, Chongqing, Chongqing 400010; 🇨🇳 Chongqing, Chongqing, China