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

NCT07413562 | Recruiting DMC

• 1 other identifier: HX-B-2024094
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Traumatic Brain Injury; Cognitive Dysfunction

Keywords

Traumatic Brain Injury; Cognitive dysfunction; Median nerve stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change in global cognitive function assessed by the Mini-Mental State Examination(MMSE)

  The MMSE will be used to evaluate global cognitive function. Assessments will be conducted by two trained occupational researchers who are blinded to group allocation and not involved in the intervention.

  Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.

Secondary Outcomes (24)

• Global cognitive function (MoCA)

  Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.

• Verbal fluency

  Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.

• Language function

  Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.

• Visuospatial function

  Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.

• Verbal learning and memory

  Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.

Other Outcomes (2)

• Feasibility outcomes

  From baseline (Day 7 after injury) to 3 months after injury.

• Safety outcomes

  From baseline (Day 7 after injury) to 3 months after injury.

Study Arms (2)

Median nerve stimulation group

EXPERIMENTAL

Participants will receive right median nerve stimulation therapy (right median nerve electrical stimulator, XCH-B1, Jiangxi Nuocheng Electrical Equipment Co., Ltd.). Both frequency of 40 Hz and pulse width of 300 µs are fixed and applied within a 20-s on/40-s off protocol. Stimulation will be administered for 8 hours per day over a 2-week period.

Device: Median nerve stimulation

Sham group

SHAM COMPARATOR

The participants in the sham stimulation group will receive no electrical stimulation (0 mA) via an activated stimulator, with all other device settings and procedures identical to those used in the active stimulation group.

Drug: Sham

Interventions

Median nerve stimulation DEVICE

Participants will receive right median nerve stimulation therapy (right median nerve electrical stimulator, XCH-B1, Jiangxi Nuocheng Electrical Equipment Co., Ltd.). Both frequency of 40 Hz and pulse width of 300 µs are fixed and applied within a 20-s on/40-s off protocol. Stimulation will be administered for 8 hours per day over a 2-week period.

Median nerve stimulation group

Sham DRUG

The participants in the sham stimulation group will receive no electrical stimulation (0 mA) via an activated stimulator, with all other device settings and procedures identical to those used in the active stimulation group.

Sham group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 (MRI), and magnetoencephalography (MEG) examinations.

You may not qualify if:

• 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 abuse.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Guoyi Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wu, MD

CONTACT

18301674233; wuliang@bjtth.org

Yu Deng, MD

CONTACT

15611308032; drdy1998@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators in charge of the recruitment and follow-up evaluation, outcome assessors, and data analysts will be blinded to group allocation. Participants and independent researchers who apply the MNS will not be blinded. Researchers who monitor patients' safety and perform risk management can access group allocation if necessary. Before the outcome assessment begins at every follow-up evaluation, the participants will be reminded not to reveal any information about their group allocation to decrease the risk of unblinding. If the investigator can detect details of group allocation during follow-up, another blinded researcher will evaluate the outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)