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Key Technologies and System Development for Assessment, Early Warning of Senile Consciousness/Cognitive Impairment and Synergistic Intervention with Multiple Physical Factors: A Randomized Controlled Trial on the Efficacy and Mechanism of Targeted Lateral Prefrontal Cortex of the Left Thalamus Stimulation via TIS for Improving Subcortical Aphasia after Stroke

Key Technologies and System Development for Assessment, Early Warning of Senile Consciousness/Cognitive Impairment and Synergistic Intervention with Multiple Physical Factors: A Randomized Controlled Trial on the Efficacy and Mechanism of Targeted Lateral Prefrontal Cortex of the Left Thalamus Stimulation via TIS for Improving Subcortical Aphasia after Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118597
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Stroke

Interventions

Channel 2: 2010 Hz
active stimulation group:For the active stimulation group, the stimulation parameters were set as follows: Channel 1: 2000 Hz
current intensity: 2 mA. Both the ramp-up and ramp-down phases lasted 30 seconds respectively, with a single stimulation session of 30 minutes. Silver/silver chloride sintered electrodes were selected
the anode of Channel 2 was placed at the posterior aspect of the scalp projection area of the same target (5 mm anterior and 3 mm superior to the T7 electrode site in the 10-20 system). The distance b

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Conforms to the diagnostic criteria for stroke adopted at the 4th National Cerebrovascular Disease Conference 2. Confirmed as stroke by cranial CT or MRI, with lesions located in the subcortical structures and restricted to the left cerebral hemisphere 3. First-onset stroke; no abnormalities in speech or cognitive function prior to the onset of the disease 4. Definite presence of subcortical lesions confirmed by cranial CT or MRI, and diagnosed as subcortical aphasia in combination with the Western Aphasia Battery (WAB) 5. Disease duration of 2 weeks to 1 year 6. Aged 35–80 years 7. Native language is Mandarin Chinese 8. Clear consciousness and able to complete scale-based assessments 9. Classified as right-handed according to the Edinburgh Handedness Inventory (EHI) 10. For participants receiving medications to improve cognition/speech (e.g., donepezil, memantine) or antidepressants, no dose adjustment shall be performed during the enrollment period.

Exclusion criteria

Exclusion criteria: 1. Subjects with coma, disturbance of consciousness, severe cognitive impairment, or other conditions that prevent cooperation with examinations. 2. Subjects complicated with severe cardiac, hepatic or renal dysfunction, severe internal diseases, or other disorders that affect language function. 3. Subjects with non-first-onset stroke, or a history of mental illness, drug dependence or alcohol dependence. 4. Subjects with contraindications to MRI scanning, such as metallic foreign bodies like cardiac pacemakers or stents implanted in the body, or a diagnosis of claustrophobia.

Design outcomes

Primary

MeasureTime frame
western aphasia battery,WAB score;

Secondary

MeasureTime frame
non-language-based cognlitive assessment,NLCA score;modified barthel index,MBI score;Amplitude of Low-Frequency Fluctuations in functional Near-Infrared Spectroscopy;Functional Connectivity in functional Near-Infrared Spectroscopy;

Countries

China

Contacts

Public ContactHu Xiquan

The Third Affiliated Hospital of Sun Yat-sen University

huxiquan@mail.sysu.edu.cn+86 189 2210 2910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026