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

NCT06723769 | Completed

• 1 other identifier: 20241204
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Post-stroke Depression

Keywords

fNIRS; LF-rTMS; DLPFC

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Scale (HAMD-17)

  evaluate the degree of depression

  pre and post 4 weeks treatment

• Functional near-infrared spectroscopy (fNIRS assessment)

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

  pre and post 4 weeks treatment

Secondary Outcomes (3)

• Hamilton Anxiety Scale(HAMA)

  pre and post 4 weeks treatment

• National Institutes of Health Stroke Scale(NIHSS)

  pre and post 4 weeks treatment

• Barthel Index(BI)

  pre and post 4 weeks treatment

Study Arms (2)

Control group

ACTIVE COMPARATOR

conventional treatment

Other: conventional treatment

rTMS group

EXPERIMENTAL

The rTMS group was treated with LF-rTMS based on the conventional treatment.

Device: rTMS treatment

Interventions

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

rTMS group

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. ).

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Dingqun Bai: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dingqun Bai

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

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 INVESTIGATOR
• PI Title: Director of rehabilitation Medicine

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: June 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CN (1)