Exploration of Repeated High-frequency Transcranial Magnetic Stimulation for the Treatment of Acute Phase Aphasia in Post-stroke Patients

NCT06787508 | Enrolling By Invitation DMC

• 1 other identifier: 2024-335-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is currently an important cause of death and disability among adults worldwide, with acute ischemic stroke being the most common type of stroke, accounting for 69.6% -72.8% of new strokes in China. The time division of the acute phase generally refers to the onset time within 1-2 weeks. About 21-38% of stroke patients have post-stroke aphasia. Post stroke aphasia is usually an acquired language disorder caused by damage to the language functional areas of the dominant hemisphere, characterized by varying degrees of impairment in some or all language functions, including speaking, listening and understanding, paraphrasing, naming, reading, and calligraphy abilities. Rehabilitation treatment for cerebral infarction should be done early rather than late. Based on this, this study aims to explore transcranial magnetic stimulation therapy for post-stroke aphasia patients in the acute phase. By regulating the balance of cortical excitability on both sides of the healthy and affected areas, early speech function rehabilitation can be achieved, which is necessary for improving the quality of life of post-stroke aphasia patients

Conditions

Stroke; Aphasia; Control Patients

Keywords

Post stroke aphasia; TMS

Outcome Measures

Primary Outcomes (1)

• BDAE Scale Score

  Collect the scores of the experimental group/control group on the Aphasia Scale before and after treatment, calculate the difference in scores for each patient and the average value of each component. Assuming that the average difference between groups is greater than 20%, it is considered that there is a significant difference

  From before treatment to 1 month after treatment, a total of 3 time points

Secondary Outcomes (1)

• Electrophysiological measurement

  From before treatment to 1 month after treatment, a total of 3 time points

Study Arms (2)

Test group

EXPERIMENTAL

Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days

Device: TMS

Control group

SHAM COMPARATOR

Consistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe, which only produces sound but does not actually produce stimulation

Device: TMS

Interventions

TMS DEVICE

Continuous high-frequency transcranial magnetic stimulation therapy Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days

Test group

Eligibility Criteria

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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Municipality Directly Under the Central Government, 400000, China

Location

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fei Xiao, Professor

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

• Jing Luo, associate professor

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Adopting double-blind method: 1) Patients do not know which group they are assigned to; 2) Physicians who group patients do not perform scale scoring and are only responsible for analyzing data before and after treatment; 3) Other neurologists who do not know the specific grouping will perform scale scoring and TMS treatment on patients before and after treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2024.12\~2025.06
• Access Criteria: After obtaining informed consent from the patients and ensuring compliance with ethical principles, this study uses Case Report Forms (CRF) and questionnaires to collect subject information. The CRFs and questionnaires are stored in both paper and electronic databases. Data collection occurs after obtaining patients' informed consent at the time of their participation in the study assessment. Two members of the research team independently enter CRF data into the electronic database, and any discrepancies are reconciled before making changes to the entry. Original paper and electronic data are registered and stored in our department's clinical trial archive cabinet.

Locations

CN (1)