Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
Healthy Volunteers
ID06493747

Efficacy and Mechanism Study of Acupuncture Combined With Neuromodulation Technology for Post-Stroke Aphasia Based on Multimodal Functional Magnetic Resonance Imaging

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

82

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how acupuncture combined with neuromodulation techniques can help treat aphasia after a stroke. Aphasia is a serious condition affecting speech and language abilities due to brain damage from stroke, especially in the left cerebral hemisphere. The study aims to assess how effective the combined treatment of acupuncture and repetitive transcranial magnetic stimulation (rTMS) is for improving language function and to explore the brain mechanisms involved in aphasia recovery. The trial has two parts. In the first part, participants are randomly assigned to two groups receiving either low-frequency rTMS followed by high-frequency rTMS or the reverse order. In the second part, participants are randomized into four groups: an experimental rTMS group with personalized treatment based on brain imaging and behavior, a standard rTMS control group, an electroacupuncture group receiving electrical stimulation at specific acupuncture points, and a group receiving both rTMS and electroacupuncture combined. Treatments are given five times a week for two weeks, with session durations ranging from 10 to 30 minutes depending on the intervention. During the study, participants undergo evaluations before treatment, immediately after the two-week intervention, and at 1, 2, and 3 months post-treatment. Assessments include language and communication tests such as the Western Aphasia Battery, Token Test, Boston Naming Test, and quality of life measurements. Brain imaging with multimodal MRI is also performed to study neural changes. The study includes safety monitoring and aims to understand both the therapeutic effects and the underlying brain function changes related to language recovery.

CONDITIONS

Brief 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 following a first stroke in the left cerebral hemisphere (including cerebral infarction and cerebral hemorrhage) by traditional Chinese and Western medical standards
  • Age between 25 and 75 years old
  • Right-handed as tested by the Edinburgh Handness Inventory
  • At least elementary school education level
  • Retain basic cognitive functions such as attention, memory, and visuospatial skills (NLCA score >70)
  • Aphasia confirmed by the Western Aphasia Battery with Aphasia Quotient (AQ) less than 93.8
  • Have some auditory comprehension and can tolerate research assessments lasting 0.5 to 1 hour
  • Understand and consent to participate, with legal guardian consent if applicable
Not Eligible

You will not qualify if you...

  • Moderate to severe dysarthria as assessed by the Frenchay Dysarthria Assessment
  • Severe speech apraxia 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 like cardiopulmonary disease or infectious diseases that prevent rehabilitation
  • Significant sleep disorders or mental disorders
  • Pregnant or breastfeeding women
  • Contraindications for MRI, including metal implants or electronic devices in the body

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive assigned interventions including various combinations of low- and high-frequency rTMS, acupuncture, or both over two weeks to improve language function after stroke.

5 sessions per week, each lasting 10 to 30 minutes

Follow-up

Duration - 3 months

Participants undergo assessments to evaluate recovery and treatment effects at 1, 2, and 3 months after the treatment ends.

3 follow-up visits (in-person) at 1, 2, and 3 months post-treatment

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.

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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