Clinical trial NCT06313866: the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI
Official title: the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Hangzhou Medical College
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 220
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MoCA
timeFrame: 0,4 weeks after the intervention, 8 weeks after the intervention
Secondary outcomes:
measure: MMSE
timeFrame: 0,4 weeks after the intervention,8 weeks after the intervention
measure: MBI
timeFrame: 0,4 weeks after the intervention,8 weeks after the intervention
measure: TCD
timeFrame: 0,4 weeks after the intervention
measure: Near-infrared functional imaging of the brain
timeFrame: 0,4 weeks after the intervention
measure: Magnetic resonance scanning
timeFrame: 0,4 weeks after the intervention
measure: the State Trait Anxiety Inventory (STAI)
timeFrame: 0,4 weeks after the intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
state: Zhejiang
Study officials:
affiliation: hangzhou medical colleage
name: Xinyun Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: