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The efficacy and safety of trigeminal nerve stimulation in the treatment of post-stroke cognitive impairment: a double-blind, randomized controlled clinical trial

The efficacy and safety of trigeminal nerve stimulation in the treatment of post-stroke cognitive impairment: a double-blind, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098180
Enrollment
Unknown
Registered
2025-03-04
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Post-stroke cognitive impairment

Interventions

Test group:Trigeminal nerve stimulation
Control group:Conventional rehabilitation

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for post-stroke cognitive impairment in Expert Consensus on the Management of Post-Stroke Cognitive Impairment ; (2) First cerebral infarction or cerebral hemorrhage confirmed by MRI or CT imaging; (3) MoCA score =18 years old, native Chinese; (5) Right-handedness in the Edinburg chirality questionnaire; (6) Clear mind, stable vital signs, can remain seated for more than 30 minutes, can receive fNIRS, EEG, fMRI and other examinations and follow-up treatment; (7) Normal cognitive function was assessed by informant questionnaire on cognitivedeclineinthe elderly (IQCODE) before stroke; (8) Patients or their families agree to participate in the trial and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Abnormal vital signs (blood pressure, heart rate, etc.) or diagnosed severe primary disease, not suitable for cognitive rehabilitation treatment; (2) Impairment of consciousness, severe neurological deficit, aphasia, deafness, blindness and other physical diseases affecting cognitive function, unable to complete behavioral assessment; (3) Those who have skull defects and have not undergone skull repair for the time being; (4) Patients with cognitive impairment caused by other primary or secondary neurological diseases (such as Alzheimer's disease, Parkinson's disease, etc.) other than stroke; (5) Depression Self-Rating Scale (SDS) score >=50 points or Anxiety Self-Rating Scale (SAS) score >=50 points.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale (MoCA) score;—

Secondary

MeasureTime frame
Mini-mental state examination;Modified Barthel Index;—

Countries

China

Contacts

Public ContactChao Ma

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

machao@mail.sysu.edu.cn+86 136 8886 9781

Outcome results

None listed

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