Thread Embedding vs. Electroacupuncture for Post-Stroke Aphasia

NCT06864442 | Completed DMC

• 1 other identifier: 793/HĐĐĐ-ĐHYD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-stroke Aphasia

Keywords

Aphasia; Stroke; Catgut Thread Embedding; Electroacupuncture; Speech-Language Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse Events of Thread Embedding

  Throughout the 30-day intervention period

Other Outcomes (1)

• Baseline Characteristics

  Day 0

Study Arms (2)

Cagut Thread Embedding Group

EXPERIMENTAL

Patients received catgut thread embedding at day 0, day 10 and day 20.

Procedure: Catgut Thread Embedding

Electroacupuncture Group

ACTIVE COMPARATOR

Patients received daily electroacupuncture for 20 minutes over 30 days.

Procedure: Electroacupuncture

Interventions

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.

Also known as: Thread Embedding, Catgut Embedding

Cagut Thread Embedding Group

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.

Also known as: Electrical Acupuncture, Electrical Stimulation Acupuncture

Electroacupuncture Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loc Cong Dai Tran, MD: lead
• School of Medicine - Vietnam National University at Ho Chi Minh city: collaborator
• Traditional Medicine Hospital at Dak Lak Province: collaborator

Study Sites (1)

Traditional Medicine Hospital

Buon Ma Thuot, Dak Lak, 63100, Vietnam

Location

Related Publications (5)

• Sinanovic O, Mrkonjic Z, Zukic S, Vidovic M, Imamovic K. Post-stroke language disorders. Acta Clin Croat. 2011 Mar;50(1):79-94.

  PMID: 22034787 BACKGROUND

• 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.

  PMID: 23468019 BACKGROUND

• 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.

  PMID: 30698070 BACKGROUND

• 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.

  PMID: 17846113 BACKGROUND

• 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.

  PMID: 22031666 BACKGROUND

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Minh-Anh Ngo Le Nguyen, Doctor of Philosophy

  University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam

  STUDY CHAIR

• Linh Anh Truong, Master of Science

  Tay Nguyen University, Buon Ma Thuot City, Dak Lak Province, Vietnam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Master of Sciences

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 7, 2025
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

VN (1)