Clinical trial NCT06864442: Thread Embedding vs. Electroacupuncture for Post-Stroke Aphasia
Official title: A Randomized Controlled Trial Comparing the Efficacy of Thread Embedding and Electroacupuncture in Speech-Language Rehabilitation in Patients With Post-Stroke Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Aphasia
Keywords: Aphasia
Stroke
Catgut Thread Embedding
Electroacupuncture
Speech-Language Rehabilitation
Lead sponsor: School of Medicine - Vietnam National University at Ho Chi Minh city
Sponsor class: OTHER
Collaborators: name: School of Medicine - Vietnam National University at Ho Chi Minh city
name: Traditional Medicine Hospital at Dak Lak Province
First posted: 2025-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Boston Diagnostic Aphasia Examination (BDAE)
timeFrame: Day 0 and Day 30
measure: Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS)
timeFrame: Day 0 and Day 30
Secondary outcomes:
measure: Adverse Events of Thread Embedding
timeFrame: Throughout the 30-day intervention period
Other outcomes:
measure: Baseline Characteristics
timeFrame: Day 0
Locations:
city: Buon Ma Thuot
country: Vietnam
facility: Traditional Medicine Hospital
state: Dak Lak
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
name: Minh-Anh Ngo Le Nguyen, Doctor of Philosophy
role: STUDY_CHAIR
affiliation: Tay Nguyen University, Buon Ma Thuot City, Dak Lak Province, Vietnam
name: Linh Anh Truong, Master of Science
role: STUDY_DIRECTOR
References:
citation: Sinanovic O, Mrkonjic Z, Zukic S, Vidovic M, Imamovic K. Post-stroke language disorders. Acta Clin Croat. 2011 Mar;50(1):79-94.
citation: 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.
citation: 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.
citation: 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.
citation: 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.