Acupuncture + Neuromodulation for Post-Stroke Aphasia

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

Qualifiers

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

Treatments tested in this trial

  • Combined Low- and High-Frequency rTMS Intervention
  • Combined High- and Low-Frequency rTMS Intervention
  • rTMS
  • rTMS + Acupuncture
  • rTMS
  • Acupuncture

Treatment groups

82 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.