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

NCT06704334 | Recruiting Phase 4

• 1 other identifier: 2024-03-06
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment After Brain Injury

Outcome Measures

Primary Outcomes (1)

• to assess the MMSE score

  baseline，Day10，Day90

Secondary Outcomes (4)

• 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

Study Arms (3)

Median nerve electrical stimulation group

EXPERIMENTAL

The optimal median nerve electrical stimulation treatment was given

Other: Median nerve electrical stimulation treatment

Huperzine A injection + median nerve electrical stimulation group

EXPERIMENTAL

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.

Other: Median nerve electrical stimulation treatment; Drug: Huperzine A injection

Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group

EXPERIMENTAL

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.

Other: Median nerve electrical stimulation treatment; Drug: Huperzine A injection; Drug: Ginkgo leaf dropping pill

Interventions

Median nerve electrical stimulation treatment OTHER

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.

Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group; Huperzine A injection + median nerve electrical stimulation group; Median nerve electrical stimulation group

Huperzine A injection DRUG

intramuscular

Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group; Huperzine A injection + median nerve electrical stimulation group

Ginkgo leaf dropping pill DRUG

oral

Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over 18 years old
• Residual cognitive impairment due to brain injury
• No previous history of brain-related diseases except this one

You may not qualify if:

• 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

Sponsors & Collaborators

• Wanbangde Pharmaceutical Group Co., LTD: lead
• Ganzhou City People's Hospital: collaborator

Study Sites (1)

The Ganzhou City People's Hospital

Ganzhou, Jiangxi, 8112320, China

RECRUITING

MeSH Terms

Interventions

huperzine A

Central Study Contacts

Dong Wang

CONTACT

18007076858; 2623693068@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: November 26, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)