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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Electronuchal acupuncture group treatment

Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point).

Group Type EXPERIMENTAL

control

Intervention Type 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

Intervention Type OTHER

Electronuchal acupuncture

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.

Group Type EXPERIMENTAL

control

Intervention Type 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.

Smell therapy group treatment

Intervention Type OTHER

nasal suction intervention with volatile oil of Acorus calamus

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.

Group Type EXPERIMENTAL

control

Intervention Type 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 combined with smell and inhalation therapy group treatment

Intervention Type OTHER

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

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.

Group Type OTHER

Smell therapy group treatment

Intervention Type OTHER

nasal suction intervention with volatile oil of Acorus calamus

Sham group

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

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Electronuchal acupuncture group treatment

Electronuchal acupuncture

Intervention Type OTHER

Smell therapy group treatment

nasal suction intervention with volatile oil of Acorus calamus

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No