Skip to main content
OpenTrials
Completed

NCT Number: NCT06864442

Thread Embedding vs. Electroacupuncture for Post-Stroke Aphasia

The goal of this clinical trial was to learn if thread embedding or electroacupuncture can treat language function impairment in patients with post-stroke aphasia, a condition affecting communication after a stroke. The main questions it aimed to answer were:

Does thread embedding improve overall language function more effectively than electroacupuncture, as measured by the Goodglass and Kaplan Aphasia Severity Rating Scale (ASRS)? How do thread embedding and electroacupuncture compare in improving specific language skills, such as motor speech, sensory language, reading, and naming, as assessed by the Boston Diagnostic Aphasia Examination (BDAE)? Researchers compared thread embedding (TE group) to electroacupuncture (EA group) to see if thread embedding provides better or similar effects on language recovery.

Participants:

Underwent a 30-day intervention with language assessments at the start and end of the period.

Were randomly assigned to either the thread embedding group, receiving treatment every 10 days, or the electroacupuncture group, receiving daily 20-minute sessions.

Completed

Looking for future studies?

Notify Me

Key information

About this study

This study was designed as a randomized, open-label, parallel-group trial conducted at the Traditional Medicine Hospital in Dak Lak, Vietnam. It received ethical approval from the Biomedical Research Ethic Committee at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 739/HĐĐĐ-ĐHYD, dated December 14, 2021). The interventions were delivered by certified traditional medicine practitioners following strict protocols (STRICTA 2010).

Catgut Thread Embedding (TE group): Participants received thread embedding at the EX-HN21 acupoint.

Electroacupuncture (EA group): Participants underwent daily 20-minute sessions in 30 days.

Language function was assessed using standardized tools, and data were analyzed with R. Statistical tests (chi-square, t-tests) compared baseline characteristics and outcomes, with a significance level of p < 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with post-stroke aphasia (severity levels 0-4 on the Goodglass and Kaplan scale)
  • Aged 18 years or older
  • Fluent in Vietnamese
  • Alert and mentally competent (no psychiatric or neurological disorders affecting communication)
  • No pre-existing speech or language disorders
  • Willing to participate and provide signed informed consent
  • Treated as inpatients at the Traditional Medicine Hospital, Dak Lak

Exclusion criteria

  • Severe physical exhaustion or skin ulcers/infections at intervention sites
  • Presence of a pacemaker
  • Allergy to catgut threads
  • Post-stroke patients awaiting cranioplasty
  • Complex disease progression requiring alternative treatments during the study (data analyzed as treatment failures)

Treatment and study plan

Catgut Thread Embedding

Procedure

Catgut Thread Embedding involved implanting chromic catgut size 4.0 thread, which is attached to a 23G guide needle, into subcutaneous tissue at EX-HN21 acupoint. The guide needle was removed after insertion, while the thread remained and dissolved over 10-15 days to provide continuous stimulation.

Other names: Thread Embedding, Catgut Embedding

electroacupuncture

Procedure

Electroacupuncture was administered using four needles (0.3 × 25 mm, diameter × length) inserted at GV-20, EX-HN21, external EX-HN12, and external EX-HN13 acupoints. Electrical stimulation was delivered via the KWD-808I Multipurpose Health Device (Changzhou Yingdi Electronic Medical Device Co., China) with parameters set at 3 Hz frequency and 0.6 ms pulse width, the intensity was adjusted according to the patient's perception. Electroacupuncture was performed daily, except on Saturdays, Sundays, and Vietnamese national holidays, over a treatment course of 30 days.

Other names: Electrical Acupuncture, Electrical Stimulation Acupuncture

Primary outcomes

  1. Boston Diagnostic Aphasia Examination (BDAE)

    Time frame: Day 0 and Day 30

    The Boston Diagnostic Aphasia Examination (BDAE) is a comprehensive and standardized tool designed to evaluate specific language functions in individuals with aphasia. It provides detailed insights into various language domains, including:

    Motor speech: Assesses articulation and fluency. Sensory language: Evaluates comprehension of spoken language. Reading skills: Measures the ability to read and understand written text. Naming skills: Tests the ability to name objects or concepts.

    Each domain is scored on a scale from 0 to 4, where:

    0: Indicates severe impairment (e.g., complete inability to speak or comprehend).

    4: Reflects mild or no impairment (near-normal language function). In practice, the BDAE is administered through structured tasks such as picture naming, sentence repetition, auditory comprehension tests, and reading exercises.

  2. Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS)

    Time frame: Day 0 and Day 30

    The Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS) is a widely used tool that assesses the overall severity of aphasia. It employs a single scale ranging from 0 to 5 to summarize the general impact of aphasia on a patient's communication abilities:

    0: Very severe aphasia (e.g., no meaningful speech or comprehension). 1-2: Severe aphasia (e.g., limited speech and poor comprehension). 3-4: Moderate to mild aphasia (e.g., functional communication with noticeable deficits).

    5: Minimal or no aphasia (near-normal language function). The ASRS is typically scored based on clinical observation and interaction with the patient, focusing on their performance in everyday communication tasks like spontaneous speech, following commands, and answering questions.

Secondary outcomes

  1. Adverse Events of Thread Embedding

    Time frame: Throughout the 30-day intervention period

    Incidence of adverse events (e.g., bleeding, infection, needle shock) monitored clinically during and after the intervention period.

Other outcomes

  1. Baseline Characteristics

    Time frame: Day 0

    Baseline data were collected through patient interviews, medical records, and diagnostic tests. Demographic variables included age, categorized as ≤49, 50-69, or ≥70 years, gender, and education level, ranging from primary to post-secondary. Comorbid conditions were assessed as follows: hypertension was identified by blood pressure ≥140/90 mmHg or use of antihypertensive drugs, cardiovascular disease was determined by patient history and ECG results, diabetes was diagnosed if HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, 2-hour glucose ≥200 mg/dL, random glucose ≥200 mg/dL with symptoms, or if patients were on diabetes medication, and dyslipidemia was confirmed by LDL ≥160 mg/dL, HDL <40 mg/dL, triglycerides ≥200 mg/dL, or total cholesterol ≥240 mg/dL. Stroke-related details encompassed the type, either hemorrhagic or ischemic, time since stroke, classified as ≤1 month or >1 month, and recurrence, noted as first-time or recurrent.

Sponsors and collaborators

Lead sponsor

Loc Cong Dai Tran, MD

Other

Collaborators

  • School of Medicine - Vietnam National University at Ho Chi Minh city
  • Traditional Medicine Hospital at Dak Lak Province

Registry information

Official study title

A Randomized Controlled Trial Comparing the Efficacy of Thread Embedding and Electroacupuncture in Speech-Language Rehabilitation in Patients With Post-Stroke Aphasia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.