Clinical trial NCT06787508: Exploration of Repeated High-frequency Transcranial Magnetic Stimulation for the Treatment of Acute Phase Aphasia in Post-stroke Patients
Official title: Exploration of Repeated High-frequency Transcranial Magnetic Stimulation for the Treatment of Acute Phase Aphasia in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Aphasia
Control Patients
Keywords: Post stroke aphasia
TMS
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:1) Age ≥ 18 years old 2) Head MR confirms new onset of cerebral infarction, and aphasia symptoms are caused by cerebral infarction 3) Patient's hospitalization history is within 7 days 4) Can cooperate to complete all required inspection items and scales 5) Sign informed consent form 6) Right handed -

Exclusion Criteria:1)Patients with aphasia caused by non cerebral infarction,2) Non acute phase cerebral infarction patients with a course of more than 7 days 3) Severe neurological disorders other than stroke, such as epilepsy and hemorrhagic stroke, are combined 4) Patients with poor general condition and unable to complete relevant examinations and scale scores, such as patients with malignant arrhythmia, tumor, severe infection, malignant hypertension, diabetes hyperosmolar coma, etc 5) Previous or current comorbidities of severe mental illnesses, such as depression, schizophrenia, etc 6) Patients who have previously or currently taken sedatives or large amounts of sleep aids 7) Contraindications for combined transcranial magnetic stimulation: presence of metal or other implants (such as pacemakers) in the body 8) Pregnancy and lactation period

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Primary outcomes:
measure: BDAE Scale Score
timeFrame: From before treatment to 1 month after treatment, a total of 3 time points
Secondary outcomes:
measure: Electrophysiological measurement
timeFrame: From before treatment to 1 month after treatment, a total of 3 time points
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: municipality directly under the Central Government
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Fei Xiao, Professor
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Jing Luo, associate professor
role: PRINCIPAL_INVESTIGATOR
References: