Aphasia, RehabilitationNCT06493747
Acupuncture + Neuromodulation for Post-Stroke Aphasia
A study testing Combined Low- and High-Frequency rTMS Intervention, Combined High- and Low-Frequency rTMS Intervention and rTMS in people with Aphasia, Rehabilitation, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Rehabilitation
- What is being tested?
- Combined Low- and High-Frequency rTMS Intervention, Combined High- and Low-Frequency rTMS Intervention and rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- Aphasia confirmed by initial assessment with the Western Aphasia Battery (WAB); an Aphasia Quotient (AQ) <93.8 indicates aphasia.
- Possess a certain level of auditory comprehension and can tolerate research examinations lasting 0.5-1 hour.
- The subject and their legal guardian understand and consent to participate in this study and have jointly signed the informed consent form.
Who cannot join
- 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.
- Severe systemic diseases such as cardiopulmonary diseases that cannot tolerate rehabilitation treatment or infectious diseases.
- Significant sleep disorders or mental disorders.
- Pregnant or lactating women.
- Contraindications for MRI examination (presence of metal foreign bodies or other implanted electronic devices in the body).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, 200080
Lei Chen, 18616826195, Chenlei_zyy@163.com
About this study
Official title: Efficacy and Mechanism Study of Acupuncture Combined With Neuromodulation Technology for Post-Stroke Aphasia Based on Multimodal Functional Magnetic Resonance Imaging
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Aphasia, Rehabilitation
- Being tested
- Combined Low- and High-Frequency rTMS Intervention, Combined High- and Low-Frequency rTMS Intervention, rTMS, rTMS + Acupuncture, Acupuncture
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Low- and High-Frequency rTMS InterventionDevice
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 InterventionDevice
Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.
rTMSDevice
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 + AcupunctureDevice
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.
rTMSDevice
Also called Control Group
Participants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.
AcupunctureDevice
Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Combined Low- and High-Frequency rTMS Intervention | Experimental | 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. Receives: Device: Combined Low- and High-Frequency rTMS Intervention |
| Combined High- and Low-Frequency rTMS Intervention | Experimental | Similar to Arm A, but the order of interventions is reversed, starting with high-frequency rTMS followed by low-frequency rTMS. Receives: Device: Combined High- and Low-Frequency rTMS Intervention |
| rTMS Experimental Group: Individualized Precision rTMS Therapy | Experimental | 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). Receives: Device: rTMS |
| rTMS + Acupuncture Group: rTMS Combined with "Kaiqiao Jieyan" Acupuncture Therapy | Experimental | Participants will receive both the aforementioned rTMS therapy and "Kaiqiao Jieyan" acupuncture therapy, including specific acupoint selection and manipulation techniques. Receives: Device: rTMS + Acupuncture |
| rTMS Control Group: Conventional rTMS Intervention | Active comparator | Participants will receive conventional rTMS intervention according to the guidelines' recommended strategies. Receives: Device: rTMS |
| Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone | Active comparator | Participants will receive only "Kaiqiao Jieyan" acupuncture therapy, without rTMS intervention. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jun 2020
- Primary completionOct 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493747
- Sponsor's protocol ID
- 2020-012
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism Study of Acupuncture Combined With Neuromodulation Technology for Post-Stroke Aphasia Based on Multimodal Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06493747
- Acronym / sponsor ID
- 2020-012
- Conditions
- Aphasia, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Combined Low- and High-Frequency rTMS Intervention | Experimental | Device: Combined Low- and High-Frequency rTMS InterventionParticipants 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 High- and Low-Frequency rTMS Intervention | Experimental | Device: Combined High- and Low-Frequency rTMS InterventionSimilar to Arm A, but the order of interventions is reversed, starting with high-frequency rTMS followed by low-frequency rTMS. |
| rTMS Experimental Group: Individualized Precision rTMS Therapy | Experimental | Device: rTMSParticipants 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 + Acupuncture Group: rTMS Combined with "Kaiqiao Jieyan" Acupuncture Therapy | Experimental | Device: rTMS + AcupunctureParticipants will receive both the aforementioned rTMS therapy and "Kaiqiao Jieyan" acupuncture therapy, including specific acupoint selection and manipulation techniques. |
| rTMS Control Group: Conventional rTMS Intervention | Active comparator | Device: rTMSParticipants will receive conventional rTMS intervention according to the guidelines' recommended strategies. |
| Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone | Active comparator | Device: AcupunctureParticipants will receive only "Kaiqiao Jieyan" acupuncture therapy, without rTMS intervention. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- Aphasia confirmed by initial assessment with the Western Aphasia Battery (WAB); an Aphasia Quotient (AQ) <93.8 indicates aphasia.
Key exclusion criteria (8 listed)
- 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.
- Severe systemic diseases such as cardiopulmonary diseases that cannot tolerate rehabilitation treatment or infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Low- and High-Frequency rTMS InterventionThis 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. | Device | Combined Low- and High-Frequency rTMS Intervention |
| Combined High- and Low-Frequency rTMS InterventionSimilar to Arm A, but the sequence of low and high-frequency rTMS is reversed. | Device | Combined High- and Low-Frequency rTMS Intervention |
| rTMSParticipants receive an individualized rTMS therapy plan based on integrated analysis of assessment data, targeting specific brain areas to enhance language function recovery post-stroke. | Device | rTMS Experimental Group: Individualized Precision rTMS Therapy |
| rTMS + AcupunctureParticipants 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. | Device | rTMS + Acupuncture Group: rTMS Combined with "Kaiqiao Jieyan" Acupuncture Therapy |
| rTMSAlso: Control GroupParticipants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions. | Device | rTMS Control Group: Conventional rTMS Intervention |
| AcupunctureParticipants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation. | Device | Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone |
Primary outcome
Western Aphasia Battery (WAB)
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.
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.
5 secondary outcomes
Token Test (Abbreviated Version)
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
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).
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)
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Low- and High-Frequency rTMS Intervention, Combined High- and Low-Frequency rTMS Intervention and rTMS in people with Aphasia, Rehabilitation, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Chen, Ph.D. (18616826195, Chenlei_zyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Aphasia Battery (WAB) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.