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Completed

NCT Number: NCT06723769

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,, Chongqing, Chongqing 400010

Chongqing, Chongqing Municipality, 400010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS treatment

Device

Repetitive transcranial magnetic stimulation (rTMS) is a new physiotherapy technique for the treatment of PSD Compared to other strategies, it has the advantages of simple operation, non-invasive, painless, and safe. Studies have comprehensively shown that rTMS can effectively improve depressive symptoms in PSD patients

conventional treatment

Other

general treatment of stabilizing vital signs (such as antidepressants, stabilizing blood pressure, stabilizing blood sugar, etc. ) and conventional rehabilitation treatment (hemiplegic limb comprehensive training, swallowing speech training, cognitive perception training, etc. ).

Primary outcomes

  1. Hamilton Depression Scale (HAMD-17)

    Time frame: pre and post 4 weeks treatment

    evaluate the degree of depression

  2. Functional near-infrared spectroscopy (fNIRS assessment)

    Time frame: pre and post 4 weeks treatment

    measure brain function to determine the effect of rTMS on cerebral blood flow change

Secondary outcomes

  1. Hamilton Anxiety Scale(HAMA)

    Time frame: pre and post 4 weeks treatment

    evaluate the degree of anxiety

  2. National Institutes of Health Stroke Scale(NIHSS)

    Time frame: pre and post 4 weeks treatment

    evaluate the degree of neurological impairment

  3. Barthel Index(BI)

    Time frame: pre and post 4 weeks treatment

    evaluate the degree of daily living ability

Sponsors and collaborators

Lead sponsor

Dingqun Bai

Other

Registry information

Official study title

Efficacy and Safety of Low-frequency Repetitive Transcranial Magnetic Stimulation in Post-stroke Depression: a Randomized Controlled fNIRS Study

Acronym: PSD fNIRS rTMS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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