A randomized, double-blind controlled trial of the trigeminal nerve stimulation to improve cognitive impairment in patients with traumatic brain injury

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400088151

Enrollment

Unknown

Registered

2024-08-13

Start date

2024-08-15

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

cognitive impairment

Interventions

Intervention group:Trigeminal nerve stimulation

Conventional rehabilitation therapy

Control group:Conventional rehabilitation therapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? All patients with traumatic brain injury are diagnosed as the first traumatic brain injury after CT or MRI examination, and a traumatic brain injury patient with a unilateral hemisphere lesion ? The first disease, course of traumatic brain injury between 2 weeks and 6 months, stable vital signs, no progress in neuropathy ? Right -handed ? age 18 to 75 years ? Montreal Cognitive Assessment Scale (MoCA) score <26 ? No severe pronounced symptoms, no serious vision, hearing disorders, can complete 4 weeks treatment and cooperate with relevant evaluation and testing ? Voluntary participation and signed informed consent (signed by the patient or another authorized representative)

Exclusion criteria

Exclusion criteria: ? Complete left frontal leaf cortex damage confirmed by CT/MRI ? the history of Alzheimer's disease, Parkinson disease, brain tumor, the history of epilepsy and the risk of epilepsy seizures ? Before trauma brain injury, there is a history of stroke, dementia or cognitive disorder (evaluate through interviews and retrospective history) ? Any neuropathy and emotional disorders that may affect the test results, or use antidepressants or nerve stimulants ? The contraindications of TNS (women during pregnancy, those who have progressive neurological diseases, etc.) ? Any other factors that may affect cognitive evaluation and treatment

Design outcomes

Primary

Measure	Time frame
Montreal Cognitive Assessment;	—

Countries

China

Contacts

Public ContactChao Ma

SUN YAT-SET MEMORIAL HOSPITAL,SUN YAT-SET UNIVERSITY

machao@sysu.edu.cn+86 181 2788 0016

Outcome results

None listed

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