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

February 19, 2025 updated by: Hangzhou Medical College

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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, and sham 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. In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. 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， the heart rate,blood pressure and the State Trait Anxiety Inventory （STAI）are collected.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311000
        • Recruiting
        • the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental ADLs/ADLs.; (2) The scores on the MMSE scale must adhere to the following criteria: Less than 17 points for individuals with illiteracy, less than 20 points for those with primary school education, and less than 24 points for individuals with a middle school education or higher.; (3) Aged under 70 years; (4) No history of mental illness, clear consciousness, stable vital signs, and able to complete the scale assessment; (5) Within 6 months post-stroke, diagnosed as a patient in the recovery period of cerebral infarction (or cerebral hemorrhage) at admission; (6) Signed informed consent by the patient or their family.

Exclusion Criteria:

  • (1) Transient ischemic attack; (2) Subarachnoid hemorrhage; (3) History of severe liver or kidney diseases, mental illness, epilepsy, asthma, or obstructive pulmonary diseases; (4) Occurrence of cognitive impairment prior to stroke; (5) Severe communication barriers; (6) Substance abuse or heavy alcohol consumption; (7) Implanted cardiac pacemakers or other electronic devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Electronuchal acupuncture group treatment
Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point).
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
Experimental: Smell therapy group treatment
The volatile oil of Acorus calamus is packed in the sniffer. Smell at the sniffing end, breathe evenly, 5-10 minutes each time, 3-5 times a day, for a total of 4 weeks of treatment.
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: Smell therapy group treatment
nasal suction intervention with volatile oil of Acorus calamus
Experimental: The combined treatment
The electro-neuchal acupuncture combined with sniffing and suction therapy group is treated with sniffing and suction therapy on the basis of electro-neuchal acupuncture treatment.
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 combined with smell and inhalation therapy group treatment
On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.
Other: normal
The volatile oil of Acorus calamus is packed in the sniffer. Smell at the sniffing end, breathe evenly, 5-10 minutes each time, 3-5 times a day, for a total of 4 weeks of treatment.
Other: Smell therapy group treatment
nasal suction intervention with volatile oil of Acorus calamus
Sham Comparator: Sham group
In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.
Other: Sham stimulation
In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA
Time Frame: 0,4 weeks after the intervention, 8 weeks after the intervention
Montreal Cognitive Assessment Scale
0,4 weeks after the intervention, 8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMSE
Time Frame: 0,4 weeks after the intervention,8 weeks after the intervention
Mini-Mental State Examination
0,4 weeks after the intervention,8 weeks after the intervention
MBI
Time Frame: 0,4 weeks after the intervention,8 weeks after the intervention
Barthel index score
0,4 weeks after the intervention,8 weeks after the intervention
TCD
Time Frame: 0,4 weeks after the intervention
Transcranial Doppler examination
0,4 weeks after the intervention
Near-infrared functional imaging of the brain
Time Frame: 0,4 weeks after the intervention
Near-infrared functional imaging of the brain
0,4 weeks after the intervention
Magnetic resonance scanning
Time Frame: 0,4 weeks after the intervention
Magnetic resonance scanning
0,4 weeks after the intervention
the State Trait Anxiety Inventory (STAI)
Time Frame: 0,4 weeks after the intervention
the State Trait Anxiety Inventory (STAI)
0,4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Medical College

Investigators

  • Principal Investigator: Xinyun Li, doctor, hangzhou medical colleage

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024ZL368

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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