The Study of Ginkgo Leaf Dropping Pills and Huperzine a Injection Combined with Median Nerve Electrical Stimulation in the Treatment of Cognitive Impairment After Brain Injury

This study will conduct a single-center clinical trial to explore the initial therapeutic effect of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment After Brain Injury
• Intervention / Treatment: Drug: Huperzine A injection; Other: Median nerve electrical stimulation treatment; Drug: Ginkgo leaf dropping pill

Detailed Description

Specific experimental research methods were randomized, controlled, single-center, exploratory clinical study, through the treatment of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment, to observe the effects of their neuroprotection and cognitive function improvement.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dong Wang; Phone Number: 18007076858; Email: 2623693068@qq.com

Study Locations

• China
  • Jiang Xi province
    • Ganzhou, Jiang Xi province, China, 8112320
      • Recruiting
      • The Ganzhou City People's Hospital
      • Contact: Dong Wang
      • Contact: Dong Wang; Phone Number: 18007076858; Email: 2623693068@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be over 18 years old

  • Residual cognitive impairment due to brain injury

    • No previous history of brain-related diseases except this one

Exclusion Criteria:

• The patient had severe underlying disease and unstable vital signs

  • The patient was complicated with consciousness disorder and could not cooperate with cognitive function assessment ③ Allergic to drugs or contraindications in drug use ④ There are contraindications of median nerve electrical stimulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Median nerve electrical stimulation group; The optimal median nerve electrical stimulation treatment was given	Other: Median nerve electrical stimulation treatment; Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.
Experimental: Huperzine A injection + median nerve electrical stimulation group; Huperzine A injection can be administered before median nerve electrical stimulation to improve the therapeutic effect of electrical stimulation. Huperzine A injection: intramuscular injection, 1ml,0.2mg once a day, the course of treatment was 7 days.	Drug: Huperzine A injection; intramuscular; Other: Median nerve electrical stimulation treatment; Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.
Experimental: Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group; Huperzine A injection can be administered before median nerve electrical stimulation to improve the therapeutic effect of electrical stimulation. After the end of the electrical stimulation treatment, ginkgo biloba dropping pills were given as long-term administration to maintain the therapeutic effect. Huperzine A injection: intramuscular injection, 1ml,0.2mg once a day, the course of treatment was 7 days. Ginkgo leaf dropping pills: Oral, each pill weighs 63mg, 5 pills/time, 3 times/day, the course of treatment is 3 months.	Drug: Huperzine A injection; intramuscular; Other: Median nerve electrical stimulation treatment; Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.; Drug: Ginkgo leaf dropping pill; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to assess the MMSE score	baseline，Day10，Day90

Secondary Outcome Measures

Outcome Measure	Time Frame
to assess the MoCA score	baseline，Day10，Day90
to assess the ADAS-cog score	baseline，Day10，Day90
to assess the HAMD score	baseline，Day10，Day90
to assess the HAMA score	baseline，Day10，Day90

Collaborators and Investigators

• Sponsor: Wanbangde Pharmaceutical Group Co., LTD
• Collaborators: Ganzhou City People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognitive Dysfunction; Wounds and Injuries; Brain Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Protective Agents; Neuroprotective Agents; Cholinergic Agents; Cholinesterase Inhibitors; Huperzine A
• Other Study ID Numbers: 2024-03-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No