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Neuromodulation and Language Training for Speech Recovery after Stroke

A Randomized Controlled Trial of taVNS and Language Rehabilitation for Post-Stroke Aphasia: Insights from fNIRS Brain Connectivity Analysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111866
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Experimental Group:Combined with transauricular vagus nerve stimulation under the routine rehabilitation of SLT
Sham Stimulation Group:False stimulation similar to the auricular vagus nerve stimulation device
Standard Therapy Group:Regular language rehabilitation only
Healthy Control Group:No intervention

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 83 Years

Inclusion criteria

Inclusion criteria: 1. Matched for sex, age, and education level; aged 18 years or above; native Chinese speakers; both males and females are eligible. 2. Meet the diagnostic criteria for ischemic cerebral infarction and aphasia, with a Western Aphasia Battery-Revised (WAB-R) Aphasia Quotient of less than 93.8, and in a stable medical condition (i.e., not in the hyper-acute phase of cerebral infarction). 3. Diagnosis of ischemic stroke with a lesion in the left cerebral hemisphere, and right-handedness. 4. Absence of congenital speech, language, or cognitive impairments. 5. No history of aphasia or cognitive deficits resulting from previous strokes. 6. Provision of informed consent by signing the consent form. 7. Approval obtained from the Ethics Committee.

Exclusion criteria

Exclusion criteria: 1. Left-handedness. 2. Aphasia caused by cerebral tumors, traumatic brain injury, or other neurological disorders. 3. Presence of skin infections, ulcers in the auricular area, or other ear diseases, accompanied by conditions such as tinnitus or deafness. 4. A Mini-Mental State Examination (MMSE) score of 24 or higher. 5. Co-existing other neurological disorders such as Parkinson's disease, Alzheimer's disease, epilepsy, etc. 6. Cardiac arrhythmia, implanted cardiac pacemaker, severe cardiovascular diseases uncontrolled by medication, or other severe systemic diseases (e.g., hepatic, renal, pulmonary), or unstable vital signs. 7. History of psychiatric disorders, traumatic brain injury, or brain surgery. 8. Patients with allergic reactions or intolerance to the VNS device. 9. Having undergone VNS or similar neuromodulation therapies within the 3 months prior to enrollment. 10. Concurrent use of medications that affect the neurotransmitter system (e.g., SSRIs) or cognitive-enhancing drugs (e.g., Donepezil) during the treatment period.202

Design outcomes

Primary

MeasureTime frame
Blood Oxygen Level-Dependent Signal(BOLD Signal);Western Aphasia Battery - Revised (WAB-R); Boston Diagnostic Aphasia Examination(BDAE);Laterality Index (LI);Functional Connectivity (FC);Aphasia Battery in Chinese;

Secondary

MeasureTime frame
Wavelet Amplitude;Wavelet Phase Coherence, WPCO;

Countries

China

Contacts

Public ContactGuohui Jiang

Department of Neurology, Affiliated Hospital of North Sichuan Medical College

neurodoctor@163.com+86 152 9820 3937

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026