Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
Healthy Volunteers
NCT06493747

Acupuncture + Neuromodulation for Post-Stroke Aphasia

Led by Shanghai Yueyang Integrated Medicine Hospital · Updated on 2024-07-10

82

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Acupuncture + Neuromodulation for Post-Stroke Aphasia

Who Can Participate

Age: 25Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with aphasia after a first stroke in the left cerebral hemisphere (cerebral infarction or hemorrhage), with one-sided brain lesion
  • Aged between 25 and 75 years
  • Right-handed with at least elementary school education level
  • Basic cognitive functions intact, including attention, memory, and visuospatial skills (NLCA score >70)
  • Aphasia confirmed by Western Aphasia Battery assessment with an Aphasia Quotient (AQ) less than 93.8
  • Have some auditory comprehension and can tolerate research assessments lasting 0.5 to 1 hour
  • Participant and legal guardian understand the study, consent, and have signed informed consent form
Not Eligible

You will not qualify if you...

  • Moderate to severe dysarthria based on Frenchay Dysarthria Assessment
  • Severe speech or oral-facial apraxia
  • Significant anxiety or moderate to severe depression based on Hamilton Anxiety and Depression Scales
  • Pre-stroke speech or language disorders
  • Severe systemic diseases such as cardiopulmonary or infectious diseases preventing rehabilitation
  • Significant sleep or mental disorders
  • Pregnant or breastfeeding women
  • Contraindications for MRI such as metal implants or electronic devices in the body

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China, 200080

Actively Recruiting

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Research Team

L

Lei Chen, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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