Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2020-06-01
2025-01-31
Brief Summary
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The research is divided into two parts:
Part One:
Participants will be randomized into two groups:
Group A: Receives low-frequency rTMS followed by high-frequency rTMS. Group B: Receives high-frequency rTMS followed by low-frequency rTMS.
Part Two:
Participants will be randomized into four groups:
rTMS Experimental Group: Individualized targets and intervention methods based on integrated fMRI and behavioral data. The rTMS intervention involves continuous treatment for two weeks, 5 sessions per week, each lasting 10-25 minutes, at 80% of the active motor threshold (AMT).
rTMS Control Group: Standard rTMS protocol guided by clinical recommendations, with continuous treatment for two weeks, 5 sessions per week, each 20 minutes, at 80% AMT.
Electroacupuncture Group: Points include Speech Area 1 (Yan Yu Yi Qu 1), Speech Area 2 (Yan Yu Yi Qu 2), Fengchi (Fengchi, GB20), Tiantu (Tiantu, CV22), Tongli (Tongli, HT5), Lianquan (Lianquan, CV23), and Paralianquan (Pang Lianquan). After needle insertion and obtaining Qi, electrical stimulation is applied with a discontinuous wave at 2Hz, at a tolerable intensity for the patient, for 30 minutes each session.
Combined rTMS and Electroacupuncture Group: Combines both intervention methods as described above.
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Detailed Description
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The research is divided into two parts:
Part One:
Participants will be randomized into two groups:
Group A: Receives low-frequency rTMS followed by high-frequency rTMS. Group B: Receives high-frequency rTMS followed by low-frequency rTMS.
Part Two:
Participants will be randomized into four groups:
rTMS Experimental Group: Individualized targets and intervention methods based on integrated fMRI and behavioral data. The rTMS intervention involves continuous treatment for two weeks, 5 sessions per week, each lasting 10-25 minutes, at 80% of the active motor threshold (AMT).
rTMS Control Group: Standard rTMS protocol guided by clinical recommendations, with continuous treatment for two weeks, 5 sessions per week, each 20 minutes, at 80% AMT.
Electroacupuncture Group: Points include Speech Area 1 (Yan Yu Yi Qu 1), Speech Area 2 (Yan Yu Yi Qu 2), Fengchi (Fengchi, GB20), Tiantu (Tiantu, CV22), Tongli (Tongli, HT5), Lianquan (Lianquan, CV23), and Paralianquan (Pang Lianquan). After needle insertion and obtaining Qi, electrical stimulation is applied with a discontinuous wave at 2Hz, at a tolerable intensity for the patient, for 30 minutes each session.
Combined rTMS and Electroacupuncture Group: Combines both intervention methods as described above.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Combined Low- and High-Frequency rTMS Intervention
Participants will receive a combined intervention of low-frequency rTMS (1Hz) and high-frequency rTMS (5Hz) using an 8-shaped coil, with each frequency's treatment duration and pulse count aligning with the protocol provided.
Combined Low- and High-Frequency rTMS Intervention
This intervention involves the application of rTMS using an 8-shaped coil with a frequency of 1Hz for low-frequency stimulation and 5Hz for high-frequency stimulation, in accordance with the study protocol.
Combined High- and Low-Frequency rTMS Intervention
Similar to Arm A, but the order of interventions is reversed, starting with high-frequency rTMS followed by low-frequency rTMS.
Combined High- and Low-Frequency rTMS Intervention
Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.
rTMS Experimental Group: Individualized Precision rTMS Therapy
Participants will undergo individualized precision rTMS therapy based on integrated analysis of assessment data, with a continuous two-week intervention, 10-25 minutes per session, at an intensity of 80% of the active motor threshold (AMT).
rTMS
Participants receive an individualized rTMS therapy plan based on integrated analysis of assessment data, targeting specific brain areas to enhance language function recovery post-stroke.
rTMS + Acupuncture Group: rTMS Combined with "Kaiqiao Jieyan" Acupuncture Therapy
Participants will receive both the aforementioned rTMS therapy and "Kaiqiao Jieyan" acupuncture therapy, including specific acupoint selection and manipulation techniques.
rTMS + Acupuncture
Participants undergo a combined treatment of rTMS as described for the rTMS Experimental Group and traditional Chinese acupuncture based on the "Kaiqiao Jieyan" method, targeting specific acupoints to facilitate recovery.
rTMS Control Group: Conventional rTMS Intervention
Participants will receive conventional rTMS intervention according to the guidelines' recommended strategies.
rTMS
Participants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.
Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone
Participants will receive only "Kaiqiao Jieyan" acupuncture therapy, without rTMS intervention.
Acupuncture
Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.
Interventions
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Combined Low- and High-Frequency rTMS Intervention
This intervention involves the application of rTMS using an 8-shaped coil with a frequency of 1Hz for low-frequency stimulation and 5Hz for high-frequency stimulation, in accordance with the study protocol.
Combined High- and Low-Frequency rTMS Intervention
Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.
rTMS
Participants receive an individualized rTMS therapy plan based on integrated analysis of assessment data, targeting specific brain areas to enhance language function recovery post-stroke.
rTMS + Acupuncture
Participants undergo a combined treatment of rTMS as described for the rTMS Experimental Group and traditional Chinese acupuncture based on the "Kaiqiao Jieyan" method, targeting specific acupoints to facilitate recovery.
rTMS
Participants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.
Acupuncture
Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 25 and 75 years old, disease course of at least 1 month, no gender restrictions.
3. Right-handed as tested by the Edinburgh Handness Inventory, with at least an elementary school education level.
4. Retention of basic cognitive functions such as attention, memory, and visuospatial skills (Non-language-based Cognitive Assessment, NLCA score \>70).
5. Aphasia confirmed by initial assessment with the Western Aphasia Battery (WAB); an Aphasia Quotient (AQ) \<93.8 indicates aphasia.
6. Possess a certain level of auditory comprehension and can tolerate research examinations lasting 0.5-1 hour.
7. The subject and their legal guardian understand and consent to participate in this study and have jointly signed the informed consent form.
Exclusion Criteria
2. Severe speech apraxia or oral-facial apraxia.
3. Significant anxiety or moderate to severe depressive symptoms as assessed by the Hamilton Anxiety and Depression Scales.
4. Pre-stroke speech or language disorders.
5. Severe systemic diseases such as cardiopulmonary diseases that cannot tolerate rehabilitation treatment or infectious diseases.
6. Significant sleep disorders or mental disorders.
7. Pregnant or lactating women.
8. Contraindications for MRI examination (presence of metal foreign bodies or other implanted electronic devices in the body).
25 Years
75 Years
ALL
Yes
Sponsors
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Shanghai Yueyang Integrated Medicine Hospital
OTHER
Responsible Party
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Locations
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Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-012
Identifier Type: -
Identifier Source: org_study_id
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