Thread Embedding Vs. Electroacupuncture for Post-Stroke Aphasia

A Randomized Controlled Trial Comparing the Efficacy of Thread Embedding and Electroacupuncture in Speech-Language Rehabilitation in Patients with 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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Aphasia
• Intervention / Treatment: Procedure: Catgut Thread Embedding; Procedure: Electroacupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Dak Lak
    • Buon Ma Thuot, Dak Lak, Vietnam, 63100
      • Traditional Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cagut Thread Embedding Group; Patients received catgut thread embedding at day 0, day 10 and day 20.	Procedure: Catgut Thread Embedding; 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
Active Comparator: Electroacupuncture Group; Patients received daily electroacupuncture for 20 minutes over 30 days.	Procedure: Electroacupuncture; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Diagnostic Aphasia Examination (BDAE)	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.	Day 0 and Day 30
Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS)	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.	Day 0 and Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events of Thread Embedding	Incidence of adverse events (e.g., bleeding, infection, needle shock) monitored clinically during and after the intervention period.	Throughout the 30-day intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Characteristics	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.	Day 0

Collaborators and Investigators

• Sponsor: Loc Cong Dai Tran, MD
• Collaborators: School of Medicine - Vietnam National University at Ho Chi Minh city; Traditional Medicine Hospital at Dak Lak Province
• Investigators: Study Chair: Minh-Anh Ngo Le Nguyen, Doctor of Philosophy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; Study Director: Linh Anh Truong, Master of Science, Tay Nguyen University, Buon Ma Thuot City, Dak Lak Province, Vietnam

Publications and helpful links

General Publications

• Berthier ML, Garcia-Casares N, Walsh SF, Nabrozidis A, Ruiz de Mier RJ, Green C, Davila G, Gutierrez A, Pulvermuller F. Recovery from post-stroke aphasia: lessons from brain imaging and implications for rehabilitation and biological treatments. Discov Med. 2011 Oct;12(65):275-89.
• Sinanovic O, Mrkonjic Z, Zukic S, Vidovic M, Imamovic K. Post-stroke language disorders. Acta Clin Croat. 2011 Mar;50(1):79-94.
• Mazaux JM, Lagadec T, de Seze MP, Zongo D, Asselineau J, Douce E, Trias J, Delair MF, Darrigrand B. Communication activity in stroke patients with aphasia. J Rehabil Med. 2013 Apr;45(4):341-6. doi: 10.2340/16501977-1122.
• Gerstenecker A, Lazar RM. Language recovery following stroke. Clin Neuropsychol. 2019 Jul;33(5):928-947. doi: 10.1080/13854046.2018.1562093. Epub 2019 Jan 30.
• Lazar RM, Speizer AE, Festa JR, Krakauer JW, Marshall RS. Variability in language recovery after first-time stroke. J Neurol Neurosurg Psychiatry. 2008 May;79(5):530-4. doi: 10.1136/jnnp.2007.122457. Epub 2007 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Aphasia; Electroacupuncture; Catgut Thread Embedding; Speech-Language Rehabilitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: 793/HĐĐĐ-ĐHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

No specific plan is outlined in the document. A decision on sharing individual participant data (e.g., demographic characteristics, language assessment scores) will be determined when the article published, based on institutional policies and ethical considerations.

Directly contact the corresponding author for more information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No