An interventional study of Combined Low- and High-Frequency rTMS Intervention and Combined High- and Low-Frequency rTMS Intervention in Aphasia, Rehabilitation, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Status unknown at 1 site in China. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Not applicable, Interventional, and Treatment
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.
Aphasia is a severe disabling consequence of stroke, typically caused by damage to the cortical and subcortical structures perfused by the left middle cerebral artery. Studies have indicated that over 20% of stroke patients develop aphasia. Although most patients exhibit some degree of spontaneous recovery within the first month after stroke, a significant number still suffer from chronic deficits six months post-stroke. Conventional rehabilitation methods and traditional Chinese medicine techniques often encounter efficacy plateaus in the treatment process. Therefore, there is an urgent need for innovative language therapy strategies to maximize recovery from aphasia. Non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS), have the potential to modulate cortical excitability and plasticity. Acupuncture therapy can activate language neural functions, establish collateral cerebral vascular circulation, and reconstruct the neural circuitry of language motor control. However, when facing patients with complex post-stroke aphasia, there are certain limitations. This study employs a randomized, blinded, controlled clinical design to verify the therapeutic efficacy of acupuncture combined with transcranial magnetic stimulation in treating post-stroke aphasia and to explore the underlying brain mechanisms of 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.
372 studies on the registry are indexed under Aphasia; 90 are open to participants now.
This study's planned enrollment of 82 is above the median of 30 across 322 interventional studies indexed under Aphasia.
Browse Aphasia studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Device: Combined Low- and High-Frequency rTMS Intervention
Similar to Arm A, but the order of interventions is reversed, starting with high-frequency rTMS followed by low-frequency rTMS.
Device: Combined High- and Low-Frequency rTMS Intervention
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).
Device: rTMS
Participants will receive both the aforementioned rTMS therapy and "Kaiqiao Jieyan" acupuncture therapy, including specific acupoint selection and manipulation techniques.
Device: rTMS + Acupuncture
Participants will receive conventional rTMS intervention according to the guidelines' recommended strategies.
Device: rTMS
Participants will receive only "Kaiqiao Jieyan" acupuncture therapy, without rTMS intervention.
Device: Acupuncture
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.
Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.
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.
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.
Participants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.
Also known as: Control Group
Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.
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.
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.
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.
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.
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.
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.
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.
Started Jun 2020 (actual). Primary completion is estimated for Oct 2024, 52 months after the start.
Of 197 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 54. This study's planned 52 months is above that.
Counting every sponsor, half of 200 studies reached it within 36 months; a quarter within 19 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Yueyang Integrated Medicine Hospital