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

NCT ID: NCT06787508

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2026-09-01

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

Detailed Description

Post stroke aphasia (PSA) is an acquired communication disorder caused by brain injury, characterized by various functional impairments such as self speech, repetition, naming, auditory comprehension, reading, and writing. PSA is one of the serious sequelae of stroke, which seriously affects the quality of life of patients. Early intervention in speech therapy can to some extent restore patients' functional communication abilities. Transcranial magnetic stimulation (TMS) is currently the most widely used non-invasive therapy. TMS can generate a magnetic field through the principle of magnetoelectric conversion, which can penetrate the skull and generate a super threshold current, allowing neurons in the target brain area to discharge. High frequency rTMS (generally frequency>5HZ) is usually applied to the affected side, aiming to improve aphasia symptoms by directly promoting the excitability of the affected cortex.

The rehabilitation treatment for PSA patients often stabilizes within a few months after stroke, and early intervention may maximize potential benefits. At present, research on high-frequency rTMS is mostly limited to the subacute or chronic phase. Therefore, this study aims to explore a safe and effective TMS treatment method during the acute phase.

Conditions

Stroke; Aphasia; Control Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test group

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

Group Type: EXPERIMENTAL

TMS

Intervention Type: 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

Control group

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

Group Type: SHAM_COMPARATOR

TMS

Intervention Type: DEVICE

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

Interventions

TMS

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

Intervention Type: DEVICE

TMS

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

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fei Xiao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fei Xiao, Professor

Role: STUDY_DIRECTOR

First Affiliated Hospital of Chongqing Medical University

Jing Luo, associate professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Municipality Directly Under the Central Government, China

Countries

China

Other Identifiers

2024-335-01

Identifier Type: -

Identifier Source: org_study_id