Acupuncture + Neuromodulation for Post-Stroke Aphasia
ConditionAphasia, Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorShanghai Yueyang Integrated Medicine Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with aphasia following stroke according to both traditional Chinese and Western medical standards; first-time stroke in the left cerebral hemisphere (including cerebral infarction and cerebral hemorrhage), with unilateral lesion.
Age between 25 and 75 years old, disease course of at least 1 month, no gender restrictions.
Right-handed as tested by the Edinburgh Handness Inventory, with at least an elementary school education level.
Retention of basic cognitive functions such as attention, memory, and visuospatial skills (Non-language-based Cognitive Assessment, NLCA score >70).
Disqualifiers
Moderate to severe dysarthria as assessed by the Frenchay Dysarthria Assessment.
Severe speech apraxia or oral-facial apraxia.
Significant anxiety or moderate to severe depressive symptoms as assessed by the Hamilton Anxiety and Depression Scales.
Pre-stroke speech or language disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Combined Low- and High-Frequency rTMS Intervention
DeviceThis 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
DeviceSimilar to Arm A, but the sequence of low and high-frequency rTMS is reversed.
rTMS
DeviceParticipants 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
DeviceParticipants 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
DeviceParticipants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.
Acupuncture
DeviceParticipants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.
Treatment groups
82 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Combined Low- and High-Frequency rTMS InterventionExperimental treatment 1 intervention
Group B: Combined High- and Low-Frequency rTMS InterventionExperimental treatment 1 intervention
Group C: rTMS Experimental Group: Individualized Precision rTMS TherapyExperimental treatment 1 intervention
Group D: rTMS + Acupuncture Group: rTMS Combined with "Kaiqiao Jieyan" Acupuncture TherapyExperimental treatment 1 intervention
Group E: rTMS Control Group: Conventional rTMS InterventionActive comparator 1 intervention
Group F: Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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 outcomes
1
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.
Time frame
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.2
Boston Naming Test
The Boston Naming Test will evaluate patients' ability to name 30 common items from pictures, measuring improvements in naming abilities.
Time frame
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.3
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.
Time frame
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.4
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov