Post-stroke AphasiaNCT06864442
Thread Embedding vs. Electroacupuncture for Post-Stroke Aphasia
A study testing Catgut Thread Embedding and Electroacupuncture in people with Post-stroke Aphasia, run by Loc Cong Dai Tran, MD at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Aphasia
- What is being tested?
- Catgut Thread Embedding and Electroacupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Post-stroke Aphasia
- Being tested
- Catgut Thread Embedding, Electroacupuncture
- Keywords
- Aphasia, Stroke, Catgut Thread Embedding, Electroacupuncture, Speech-Language Rehabilitation
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catgut Thread EmbeddingProcedure or surgery
Also called Thread Embedding, Catgut 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.
ElectroacupunctureProcedure or surgery
Also called Electrical Acupuncture, Electrical Stimulation Acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| Cagut Thread Embedding Group | Experimental | Patients received catgut thread embedding at day 0, day 10 and day 20. Receives: Procedure: Catgut Thread Embedding |
| Electroacupuncture Group | Active comparator | Patients received daily electroacupuncture for 20 minutes over 30 days. Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 and Day 30
Secondary outcomes (1)
Adverse Events of Thread Embedding
Incidence of adverse events (e.g., bleeding, infection, needle shock) monitored clinically during and after the intervention period.
Measured: Throughout the 30-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-stroke AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loc Cong Dai Tran, MD
- Sponsor type
- University, hospital or other
- Collaborators
- School of Medicine - Vietnam National University at Ho Chi Minh city, Traditional Medicine Hospital at Dak Lak Province
- Responsible party
- Sponsor-investigator, Loc Cong Dai Tran, MD, School of Medicine - Vietnam National University at Ho Chi Minh city
- Investigators
- Minh-Anh Ngo Le Nguyen, Doctor of Philosophy, Study chair, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, VietnamLinh Anh Truong, Master of Science, Study director, Tay Nguyen University, Buon Ma Thuot City, Dak Lak Province, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864442
- Sponsor's protocol ID
- 793/HĐĐĐ-ĐHYD
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Sinanovic O, Mrkonjic Z, Zukic S, Vidovic M, Imamovic K. Post-stroke language disorders. Acta Clin Croat. 2011 Mar;50(1):79-94.
PubMed 22034787Mazaux 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.
PubMed 23468019Gerstenecker 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.
PubMed 30698070Lazar 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.
PubMed 17846113Berthier 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.
PubMed 22031666
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of Thread Embedding and Electroacupuncture in Speech-Language Rehabilitation in Patients With Post-Stroke Aphasia
- ClinicalTrials.gov ID
- NCT06864442
- Acronym / sponsor ID
- 793/HĐĐĐ-ĐHYD
- Conditions
- Post-stroke Aphasia
- Keywords
- Aphasia, Stroke, Catgut Thread Embedding, Electroacupuncture, Speech-Language Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Loc Cong Dai Tran, MDUniversity, hospital or other
- Collaborators
- School of Medicine - Vietnam National University at Ho Chi Minh city, Traditional Medicine Hospital at Dak Lak Province
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cagut Thread Embedding Group | Experimental | Procedure: Catgut Thread EmbeddingPatients received catgut thread embedding at day 0, day 10 and day 20. |
| Electroacupuncture Group | Active comparator | Procedure: ElectroacupuncturePatients received daily electroacupuncture for 20 minutes over 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catgut Thread EmbeddingAlso: Thread Embedding, Catgut EmbeddingCatgut 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. | Procedure or surgery | Cagut Thread Embedding Group |
| ElectroacupunctureAlso: Electrical Acupuncture, Electrical Stimulation AcupunctureElectroacupuncture 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. | Procedure or surgery | Electroacupuncture Group |
Primary outcome
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.
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.
1 secondary outcome
Adverse Events of Thread Embedding
Time frame: Throughout the 30-day intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Background: PubMed 22034787Sinanovic O, Mrkonjic Z, Zukic S, Vidovic M, Imamovic K. Post-stroke language disorders. Acta Clin Croat. 2011 Mar;50(1):79-94.
- Background: PubMed 23468019Mazaux 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.
- Background: PubMed 30698070Gerstenecker 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.
- Background: PubMed 17846113Lazar 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.
- Background: PubMed 22031666Berthier 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minh-Anh Ngo Le Nguyen, Doctor of Philosophy study chair
University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
Linh Anh Truong, Master of Science study director
Tay Nguyen University, Buon Ma Thuot City, Dak Lak Province, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catgut Thread Embedding and Electroacupuncture in people with Post-stroke Aphasia, run by Loc Cong Dai Tran, MD at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Diagnostic Aphasia Examination (BDAE) (time frame: Day 0 and Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06864442, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.