Stroke
Conditions
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.
Interventions
DIETARY_SUPPLEMENTcontrol
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.
OTHERElectronuchal acupuncture group treatment
Electronuchal acupuncture
OTHERSmell therapy group treatment
nasal suction intervention with volatile oil of Acorus calamus
OTHERElectronuchal acupuncture combined with smell and inhalation therapy group treatment
On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.
OTHERSham stimulation
In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.
Sponsors
Hangzhou Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MoCA | 0,4 weeks after the intervention, 8 weeks after the intervention | Montreal Cognitive Assessment Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| MMSE | 0,4 weeks after the intervention,8 weeks after the intervention | Mini-Mental State Examination |
| 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) |
| Near-infrared functional imaging of the brain | 0,4 weeks after the intervention | Near-infrared functional imaging of the brain |
Countries
China
Contacts
Primary ContactXinyun Dr LI, Doctor
Outcome results
None listed