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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Другое Electronuchal acupuncture group treatment
  Electronuchal acupuncture
• Другое Smell therapy group treatment
  nasal suction intervention with volatile oil of Acorus calamus
• Другое Electronuchal acupuncture combined with smell and inhalation therapy group treatment
  On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.
• Другое Sham stimulation
  In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.

Первичные конечные точки

• MoCA [Срок оценки: 0,4 weeks after the intervention, 8 weeks after the intervention]

Вторичные конечные точки (6)

• MMSE [Срок оценки: 0,4 weeks after the intervention,8 weeks after the intervention]
• MBI [Срок оценки: 0,4 weeks after the intervention,8 weeks after the intervention]
• TCD [Срок оценки: 0,4 weeks after the intervention]
• Near-infrared functional imaging of the brain [Срок оценки: 0,4 weeks after the intervention]
• Magnetic resonance scanning [Срок оценки: 0,4 weeks after the intervention]
• the State Trait Anxiety Inventory (STAI) [Срок оценки: 0,4 weeks after the intervention]

Критерии участия

Критерии включения

• (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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT06313866 · 2024ZL368

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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