the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI
- Conditions
- Stroke
- Interventions
- Dietary Supplement: controlOther: Smell therapy group treatmentOther: Electronuchal acupuncture group treatmentOther: Electronuchal acupuncture combined with smell and inhalation therapy group treatment
- Registration Number
- NCT06313866
- Lead Sponsor
- Hangzhou Medical College
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- (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.
- (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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electronuchal acupuncture group treatment Electronuchal acupuncture group treatment Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point). Smell therapy group treatment control 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. Electronuchal acupuncture group treatment control Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point). normal 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. Smell therapy group treatment 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. The combined treatment control 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. The combined treatment Electronuchal acupuncture combined with smell and inhalation therapy group 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.
- Primary Outcome Measures
Name Time Method MoCA 0,4 weeks after the intervention, 8 weeks after the intervention Montreal Cognitive Assessment Scale
- Secondary Outcome Measures
Name Time Method MMSE 0,4 weeks after the intervention,8 weeks after the intervention Mini-Mental State Examination
MBI 0,4 weeks after the intervention,8 weeks after the intervention Barthel index score
TCD 0,4 weeks after the intervention Transcranial Doppler examination
Near-infrared functional imaging of the brain 0,4 weeks after the intervention Near-infrared functional imaging of the brain
Magnetic resonance scanning 0,4 weeks after the intervention Magnetic resonance scanning
the State Trait Anxiety Inventory (STAI) 0,4 weeks after the intervention the State Trait Anxiety Inventory (STAI)
Trial Locations
- Locations (1)
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
🇨🇳Hangzhou, Zhejiang, China