Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT07413562

Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury

Led by Beijing Tiantan Hospital · Updated on 2026-02-17

30

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Currently, the treatment of cognitive dysfunction after acute TBI remains a challenge, and novel therapeutic methods are urgently needed. Median nerve stimulation (MNS) is a non-invasive neuromodulation technique and recently has shown positive effects in awaking coma of acute brain injury. It has been shown to improve cognition in healthy volunteers and may be a potential therapeutic approach for cognitive dysfunction in patients with acute TBI. Therefore, the main purpose of the study is to evaluate the feasibility, safety, and preliminary efficacy of MNS for cognitive dysfunction in patients with acute TBI.

CONDITIONS

Official Title

Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-64 years
  • Admitted within 3 days after injury with Glasgow Coma Scale score of 9-12 and imaging abnormalities
  • Cognitive dysfunction within 1 week after injury with Mini-Mental State Examination score 26 or below
  • Pre-injury Clinical Dementia Rating score of 0 as reported by family
  • At least 6 years of education and able to understand instructions and cooperate with assessments, MRI, and MEG examinations
Not Eligible

You will not qualify if you...

  • Need for emergency neurosurgical intervention such as surgery or device placement
  • Unstable vital signs or unstable cardiac, pulmonary, liver, kidney, or blood system disorders
  • Pre-existing central nervous system conditions causing cognitive decline, including previous traumatic brain injury, brain infection, brain tumor, epilepsy, stroke, neurodegenerative diseases, carbon monoxide poisoning, or alcohol abuse
  • Severe visual or hearing impairment, psychiatric or behavioral disorders, MRI contraindications, or intolerance to MEG
  • Short life expectancy due to critical illness
  • Right forearm skin lesions, right median nerve injury, brachial plexus injury, cervical spinal cord injury, or intolerance to median nerve stimulation
  • Pregnant or breastfeeding women
  • Participation in other ongoing clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

L

Liang Wu, MD

CONTACT

Y

Yu Deng, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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