the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI

Stroke Clinical Trial

Official title:

the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313866
• Other study ID #: 2024ZL368
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Hangzhou Medical College
• Contact: Xinyun Dr LI, Doctor
• Phone: 8618069783240
• Email: lxyjasmine2010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated.

Description:

The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, with 35 people in each group. All patients were treated with conventional drugs and general supportive treatment, and on the basis of this, the electroacupuncture group was given electroacupuncture treatment at bilateral Fengchi and Gongxue, the smell suction therapy group was given the intervention of volatile oil nasal suction of Acorus calamus, and the electroacupuncture group combined with smell and suction therapy group was given electroacupuncture treatment at the same time as the electroacupuncture treatment of bilateral Fengchi and Gongxue. After the 1 month innervation,the main efficacy indicators: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Barthel Index (MBI) score, and the secondary efficacy indicators: Transcranial Doppler (TCD), near-infrared functional brain imaging , magnetic resonance examination are collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• (1) Comply with the diagnostic standards of Chinese medicine and Western medicine; (2) Meet the above MMSE and MoCA scale scoring criteria; (3) There is no gender limit, and the age is less than 70 years old; (4) No history of mental illness, clear consciousness, stable vital signs, can cooperate with the completion of the scale filling; (5) Patients with a diagnosis of cerebral infarction (or cerebral hemorrhage) in the recovery period within 6 months after stroke; (6) The patient or his/her family members sign the informed consent form

Exclusion Criteria:

• (1) Author of transient cerebral ischemia; (2) Patients with subarachnoid hemorrhage; (3) History of malignant diseases in the past; (4) Previous history of mental illness; (5) Previous history of epilepsy; (6) Previous history of asthma and obstructive pulmonary disease; (7) The patient's cognitive impairment occurred before stroke; (8) Those with severe communication difficulties; (9) The age of the patient is higher than or equal to 70 years old; (10) Admitted to the hospital and diagnosed as the sequelae of cerebral infarction (or cerebral hemorrhage) (the course of the disease is greater than 6 months); (11) Those who abuse drugs and drink a lot.

Related Conditions & MeSH terms

• Stroke

Intervention

Dietary Supplement:
• control
Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks.

Other:
• Electronuchal acupuncture group treatment
Electronuchal acupuncture
• Smell therapy group treatment
nasal suction intervention with volatile oil of Acorus calamus
• Electronuchal acupuncture combined with smell and inhalation therapy group treatment
On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.

Locations

Country	Name	City	State
China	the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMSE	Mini-Mental State Examination	4 weeks after the intervention
Primary	MoCA	Montreal Cognitive Assessment Scale	4 weeks after the intervention
Primary	MBI	Barthel index score	4 weeks after the intervention
Secondary	TCD	Transcranial Doppler examination	4 weeks after the intervention
Secondary	Near-infrared functional imaging of the brain	Near-infrared functional imaging of the brain	4 weeks after the intervention
Secondary	Magnetic resonance scanning	Magnetic resonance scanning	4 weeks after the intervention