Acupuncture + Neuromodulation for Post-Stroke Aphasia
NCT Number: NCT06493747
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aphasia, Rehabilitation
Interventions: DEVICE: Combined Low- and High-Frequency rTMS Intervention|DEVICE: Combined High- and Low-Frequency rTMS Intervention|DEVICE: rTMS|DEVICE: rTMS + Acupuncture|DEVICE: rTMS|DEVICE: Acupuncture
Sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-06-01
Completion Date: 2025-01
Locations: Shanghai Yueyang Integrated Medicine Hospital, Shanghai, Shanghai, 200080, China

Summary:
The aim of this clinical trial is to assess the therapeutic efficacy of acupuncture combined with neuromodulation techniques for the treatment of post-stroke aphasia and to explore the brain mechanisms involved. The study seeks to answer two primary questions: the effectiveness of the integrated intervention of acupuncture and repetitive transcranial magnetic stimulation (rTMS) on post-stroke aphasia, and the mechanisms underlying language function impairment and recovery.

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.

Primary Outcome Measures: Western Aphasia Battery (WAB), Western Aphasia Battery (WAB): Assesses aphasia severity in speech, comprehension, reading, and writing. Score Range: WAB-derived AQ scores range from 0 (severe impairment) to 100 (no impairment). Interpretation: Higher AQ scores on the WAB indicate better language function in aphasia patients., Baseline: Pre-intervention assessment. Immediately Post-Intervention: Assessment at the end of the 2-week intervention. Follow-Up Assessments: Assessments are also conducted at 1, 2, and 3 months post-intervention.
Secondary Outcome Measures: Token Test (Abbreviated Version), Token Test (Abbreviated Version): The abbreviated Token Test will be utilized to evaluate patients' spoken language comprehension and abstract thinking abilities. This assessment will provide insights into the participants' cognitive and linguistic capacities., Baseline: Pre-intervention assessment. Immediately Post-Intervention: Assessment at the end of the 2-week intervention. Follow-Up Assessments: Assessments are also conducted at 1, 2, and 3 months post-intervention.|Boston Naming Test, The Boston Naming Test will evaluate patients' ability to name 30 common items from pictures, measuring improvements in naming abilities., Baseline: Pre-intervention assessment. Immediately Post-Intervention: Assessment at the end of the 2-week intervention. Follow-Up Assessments: Assessments are also conducted at 1, 2, and 3 months post-intervention.|American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS)., ASHA FACS assesses functional communication in aphasia, including basic needs and social integration. Score Range - Communicative Independence Scale: 1 (maximal assistance) to 7 (independence) across 43 items. Score Range - Qualitative Dimensions Scale: 1 (poor quality) to 5 (excellent quality). Interpretation: Higher scores indicate better communication outcomes in aphasia., Baseline: Pre-intervention assessment. Immediately Post-Intervention: Assessment at the end of the 2-week intervention. Follow-Up Assessments: Assessments are also conducted at 1, 2, and 3 months post-intervention.|Stroke-Specific Quality of Life Scale (SS-QOL), The Stroke-Specific Quality of Life Scale (SS-QOL) is used to evaluate the health-related quality of life in stroke patients, focusing on the specific impacts of stroke on daily living and well-being. Scale Title: Stroke-Specific Quality of Life Scale (SS-QOL). Score Range: The SS-QOL score ranges from 1.0 (lowest quality of life) to 5.0 (highest quality of life). Interpretation: Higher scores indicate a better quality of life for stroke survivors., Baseline: Pre-intervention assessment. Immediately Post-Intervention: Assessment at the end of the 2-week intervention. Follow-Up Assessments: Assessments are also conducted at 1, 2, and 3 months post-intervention.|Multimodal MRI Assessment, This includes 3D structural MRI (sMRI), functional MRI (fMRI) during task performance and at rest, and Diffusion Tensor Imaging (DTI) to evaluate changes in brain structure and function., Baseline: Pre-intervention assessment. Immediately Post-Intervention: Assessment at the end of the 2-week intervention. Follow-Up Assessments: Assessments are also conducted at 1, 2, and 3 months post-intervention.