Acupuncture + Neuromodulation for Post-Stroke Aphasia

Shanghai Yueyang Integrated Medicine Hospital

Status

Enrolling

Conditions

Aphasia, Rehabilitation

Treatments

Device: rTMS + Acupuncture

Device: Combined Low- and High-Frequency rTMS Intervention

Device: Acupuncture

Device: rTMS

Device: Combined High- and Low-Frequency rTMS Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06493747

2020-012

Details and patient eligibility

About

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.

Full 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 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.

Combined rTMS and Electroacupuncture Group: Combines both intervention methods as described above.

Enrollment

82 estimated patients

Sex

All

Ages

25 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 6 patient groups

Combined Low- and High-Frequency rTMS Intervention

Experimental group

Description:

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.

Treatment:

Device: Combined Low- and High-Frequency rTMS Intervention

Combined High- and Low-Frequency rTMS Intervention

Experimental group

Description:

Similar to Arm A, but the order of interventions is reversed, starting with high-frequency rTMS followed by low-frequency rTMS.

Treatment:

Device: Combined High- and Low-Frequency rTMS Intervention

rTMS Experimental Group: Individualized Precision rTMS Therapy

Experimental group

Description:

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).

Treatment:

Device: rTMS

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

Experimental group

Description:

Participants will receive both the aforementioned rTMS therapy and "Kaiqiao Jieyan" acupuncture therapy, including specific acupoint selection and manipulation techniques.

Treatment:

Device: rTMS + Acupuncture

rTMS Control Group: Conventional rTMS Intervention

Active Comparator group

Description:

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

Treatment:

Device: rTMS

Acupuncture Group: "Kaiqiao Jieyan" Acupuncture Therapy Alone

Active Comparator group

Description:

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