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Tests treatment safety and results for Traumatic Brain Injury
Official title Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury
ClinicalTrials.gov ID: NCT07413562
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Aged 18-64 years.
- Admitted within 3 days post-injury with a Glasgow Coma Scale (GCS) score of 9-12 at admission, accompanied by imaging abnormalities.
- Presence of cognitive dysfunction assessed within 1-week after injury, with a Mini-Mental State Examination (MMSE) score ≤26.
- Pre-injury Clinical Dementia Rating (CDR) score = 0 as reported by family members.
- With a pre-injury education of ≥6 years, able to comprehend instructions and cooperate in completing scale assessments, magnetic resonance imaging...
You likely can't join if
- Requirement for emergent neurosurgical intervention during treatment including surgery, intracranial pressure monitoring device placement, or...
- Unstable vital signs or hemodynamics, or presence of unstable cardiac, pulmonary, hepatic, renal, or hematopoietic system disorders.
- Pre-existing central nervous system conditions causing cognitive decline: traumatic brain injury, intracranial infection, brain tumor, epilepsy...
- Inability to complete assessments or examinations due to severe visual or auditory impairment, severe psychiatric or behavioral disorders, MRI...
- Short life expectancy due to critical illnesses.
- Right forearm with extensive skin lesions or scars, right median nerve injury, brachial plexus injury, cervical spinal cord injury, or intolerance to...
See the full eligibility criteria
- Aged 18-64 years.
- Admitted within 3 days post-injury with a Glasgow Coma Scale (GCS) score of 9-12 at admission, accompanied by imaging abnormalities.
- Presence of cognitive dysfunction assessed within 1-week after injury, with a Mini-Mental State Examination (MMSE) score ≤26.
- Pre-injury Clinical Dementia Rating (CDR) score = 0 as reported by family members.
- With a pre-injury education of ≥6 years, able to comprehend instructions and cooperate in completing scale assessments, magnetic resonance imaging (MRI), and magnetoencephalography (MEG) examinations.
- Requirement for emergent neurosurgical intervention during treatment including surgery, intracranial pressure monitoring device placement, or drainage catheter insertion.
- Unstable vital signs or hemodynamics, or presence of unstable cardiac, pulmonary, hepatic, renal, or hematopoietic system disorders.
- Pre-existing central nervous system conditions causing cognitive decline: traumatic brain injury, intracranial infection, brain tumor, epilepsy, stroke, neurodegenerative diseases, carbon monoxide poisoning, and alcohol...
- Inability to complete assessments or examinations due to severe visual or auditory impairment, severe psychiatric or behavioral disorders, MRI contraindications, and MEG intolerance.
- Short life expectancy due to critical illnesses.
- Right forearm with extensive skin lesions or scars, right median nerve injury, brachial plexus injury, cervical spinal cord injury, or intolerance to MNS.
- Pregnant or lactating women.
- Participation in other ongoing clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.