StrokeNCT06313866
the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI
A study testing Electronuchal acupuncture group treatment, Smell therapy group treatment and Electronuchal acupuncture combined with smell and inhalation therapy group treatment in people with Stroke, run by Hangzhou Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Electronuchal acupuncture group treatment, Smell therapy group treatment and Electronuchal acupuncture combined with smell and inhalation therapy group treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
Hangzhou, Zhejiang, 311000
Xinyun Dr LI, Doctor, 8618069783240, lxyjasmine2010@163.com
About this study
Official title: the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- control, Electronuchal acupuncture group treatment, Smell therapy group treatment, Electronuchal acupuncture combined with smell and inhalation therapy group treatment, Sham stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlDietary 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 treatmentOther
Electronuchal acupuncture
Smell therapy group treatmentOther
nasal suction intervention with volatile oil of Acorus calamus
Electronuchal acupuncture combined with smell and inhalation therapy group treatmentOther
On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.
Sham stimulationOther
In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | 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 | Experimental | Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point). Receives: Dietary Supplement: control; Other: Electronuchal acupuncture group treatment |
| Smell therapy group treatment | Experimental | 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. Receives: Dietary Supplement: control; Other: Smell therapy group treatment |
| The combined treatment | Experimental | 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. Receives: Dietary Supplement: control; Other: Electronuchal acupuncture combined with smell and inhalation therapy group treatment |
| normal | Other | 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. Receives: Other: Smell therapy group treatment |
| Sham group | Sham comparator | In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA
Montreal Cognitive Assessment Scale
Measured: 0,4 weeks after the intervention, 8 weeks after the intervention
Secondary outcomes (6)
MMSE
Mini-Mental State Examination
Measured: 0,4 weeks after the intervention,8 weeks after the intervention
MBI
Barthel index score
Measured: 0,4 weeks after the intervention,8 weeks after the intervention
TCD
Transcranial Doppler examination
Measured: 0,4 weeks after the intervention
Near-infrared functional imaging of the brain
Near-infrared functional imaging of the brain
Measured: 0,4 weeks after the intervention
Magnetic resonance scanning
Magnetic resonance scanning
Measured: 0,4 weeks after the intervention
the State Trait Anxiety Inventory (STAI)
the State Trait Anxiety Inventory (STAI)
Measured: 0,4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyun Li, doctor, Principal investigator, hangzhou medical colleage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313866
- Sponsor's protocol ID
- 2024ZL368
- Status last verified
- Nov 2024
- First submitted
- 10 Mar 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke
- ClinicalTrials.gov ID
- NCT06313866
- Acronym / sponsor ID
- 2024ZL368
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hangzhou Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –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 | Experimental | Dietary Supplement: control, Other: Electronuchal acupuncture group treatmentUse the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point). |
| Smell therapy group treatment | Experimental | Dietary Supplement: control, Other: Smell therapy group treatmentThe 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 | Experimental | Dietary Supplement: control, Other: Electronuchal acupuncture combined with smell and inhalation therapy group treatmentThe 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. |
| normal | Other | Other: Smell therapy group treatmentThe 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. |
| Sham group | Sham comparator | Other: Sham stimulationIn the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlDonepezil 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. | Dietary supplement | Electronuchal acupuncture group treatment, Smell therapy group treatment, The combined treatment |
| Electronuchal acupuncture group treatmentElectronuchal acupuncture | Other | Electronuchal acupuncture group treatment |
| Smell therapy group treatmentnasal suction intervention with volatile oil of Acorus calamus | Other | Smell therapy group treatment, normal |
| Electronuchal acupuncture combined with smell and inhalation therapy group treatmentOn the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given. | Other | The combined treatment |
| Sham stimulationIn the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. | Other | Sham group |
Primary outcome
MoCA
Time frame: 0,4 weeks after the intervention, 8 weeks after the intervention
Montreal Cognitive Assessment Scale
6 secondary outcomes
MMSE
Time frame: 0,4 weeks after the intervention,8 weeks after the intervention
MBI
Time frame: 0,4 weeks after the intervention,8 weeks after the intervention
TCD
Time frame: 0,4 weeks after the intervention
Near-infrared functional imaging of the brain
Time frame: 0,4 weeks after the intervention
Magnetic resonance scanning
Time frame: 0,4 weeks after the intervention
the State Trait Anxiety Inventory (STAI)
Time frame: 0,4 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinyun Li, doctor principal investigator
hangzhou medical colleage
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronuchal acupuncture group treatment, Smell therapy group treatment and Electronuchal acupuncture combined with smell and inhalation therapy group treatment in people with Stroke, run by Hangzhou Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyun Dr LI, Doctor (8618069783240, lxyjasmine2010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (time frame: 0,4 weeks after the intervention, 8 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.