Acupuncture + Neuromodulation for Post-Stroke Aphasia

NCT06493747 | Recruiting DMC

• 1 other identifier: 2020-012
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aphasia, Rehabilitation

Outcome Measures

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.

  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)

  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

  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).

  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)

  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

  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.

Study Arms (6)

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.

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.

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).

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.

Device: rTMS + Acupuncture

rTMS Control Group: Conventional rTMS Intervention

ACTIVE COMPARATOR

Participants will receive conventional rTMS intervention according to the guidelines' recommended strategies.

Device: rTMS

Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone

ACTIVE COMPARATOR

Participants will receive only "Kaiqiao Jieyan" acupuncture therapy, without rTMS intervention.

Device: Acupuncture

Interventions

Combined Low- and High-Frequency rTMS Intervention DEVICE

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 Low- and High-Frequency rTMS Intervention

Combined High- and Low-Frequency rTMS Intervention DEVICE

Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.

Combined High- and Low-Frequency rTMS Intervention

rTMS DEVICE

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 Experimental Group: Individualized Precision rTMS Therapy

rTMS + Acupuncture DEVICE

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 + Acupuncture Group: rTMS Combined with "Kaiqiao Jieyan" Acupuncture Therapy

Acupuncture DEVICE

Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.

Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Aphasia

Interventions

Transcranial Magnetic Stimulation; Acupuncture Therapy; Control Groups

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Complementary Therapies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Lei Chen, Ph.D.

CONTACT

18616826195; Chenlei_zyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 10, 2024
• Study Start: June 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

CN (1)