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NCT Number: NCT06313866

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

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.

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Key information

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.

Hangzhou, Zhejiang, 311000, China

Location status: Recruiting

Location contact

Xinyun Dr LI, Doctor

CONTACT

[email protected]

8618069783240

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Dietary Supplement

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.

Electronuchal acupuncture group treatment

Other

Electronuchal acupuncture

Smell therapy group treatment

Other

nasal suction intervention with volatile oil of Acorus calamus

Electronuchal acupuncture combined with smell and inhalation therapy group treatment

Other

On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.

Sham stimulation

Other

In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.

Primary outcomes

  1. MoCA

    Time frame: 0,4 weeks after the intervention, 8 weeks after the intervention

    Montreal Cognitive Assessment Scale

Secondary outcomes

  1. MMSE

    Time frame: 0,4 weeks after the intervention,8 weeks after the intervention

    Mini-Mental State Examination

  2. MBI

    Time frame: 0,4 weeks after the intervention,8 weeks after the intervention

    Barthel index score

  3. TCD

    Time frame: 0,4 weeks after the intervention

    Transcranial Doppler examination

  4. Near-infrared functional imaging of the brain

    Time frame: 0,4 weeks after the intervention

    Near-infrared functional imaging of the brain

  5. Magnetic resonance scanning

    Time frame: 0,4 weeks after the intervention

    Magnetic resonance scanning

  6. the State Trait Anxiety Inventory (STAI)

    Time frame: 0,4 weeks after the intervention

    the State Trait Anxiety Inventory (STAI)

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyun Dr LI, Doctor

CONTACT

[email protected]

8618069783240

Sponsors and collaborators

Lead sponsor

Hangzhou Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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