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Investigation on the Association Between Olfactory Function and Cognitive Impairment After Stroke and Therapeutic Efficacy of Central Olfactory Neuromodulation for Post-Stroke Cognitive Impairment

Investigation on the Association Between Olfactory Function and Cognitive Impairment After Stroke and Therapeutic Efficacy of Central Olfactory Neuromodulation for Post-Stroke Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106744
Enrollment
Unknown
Registered
2025-07-29
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Experiment 2:Stroke Patient group:All the subjects were subjected to the MoCA, MMSE, Sniffin' Sticks olfactory test and rs-fMRI scans.
Experiment 1:Healthy Control group:All the subjects were subjected to the MoCA, MMSE, Sniffin' Sticks olfactory test and rs-fMRI scans.
Experiment 2:Olfactory Training group:Using four odors: phenylethanol (rose), eucalyptol (eucalyptus), citronellal (lemon), and eugenol (clove), each odor was smelled for about 10 seconds. The two odo
Experiment 2:control group:Conventional cognitive rehabilitation training is adopted. Professional and qualified cognitive therapists conduct regular cognitive training for the patients, including mem
Experiment 3:TI group:The non-invasive deep brain stimulation system with frequency difference interference technology, produced by Soterix Medical Inc of the United States, model: 0113S, was adopted.
PO9 -0.95mA
Ex 13 1.05mA
Ex18 -1.05mA. The frequencies were 1300 Hz and 1430 Hz respectively, thereby generating an interference electric field frequency of 130 Hz. The total stimulation duration was 20 minutes, includin

Sponsors

Zhongda Hospital of Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: Experiment 1: Stroke Patients: 1) Meets the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023" for cerebral infarction and "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage (2019)" for cerebral hemorrhage; 2) First-time stroke, with a disease course of no more than 6 months; 3) Age between 25 and 75 years old, with no gender restrictions; 4) Clear consciousness, stable clinical condition, and able to follow instructions and cooperate to complete the required clinical assessment and head MRI scan; 5) Native language is Mandarin Chinese, with an education level of primary school or above; 6) All participants are aware of the trial details, agree to participate in the trial, and sign the informed consent form. Healthy subjects: 1) Age 25 - 75 years old, gender not restricted; 2) Clear consciousness, able to follow instructions and cooperate to complete the required clinical assessment and head MRI scan; 3) Native language is Mandarin Chinese, educational level is primary school or above; 4) All subjects are aware of the trial details, agree to participate in this trial, and sign the informed consent form. Experiment 2 and Experiment 3: 1) Meets the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023" for cerebral infarction and "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage (2019)" for cerebral hemorrhage; 2) First-time stroke, with a disease course of no more than 6 months; 3) MoCA score < 26 points; 4) Age between 25 and 75 years old, with no gender restrictions; 5) Clear consciousness, stable clinical condition, and able to follow instructions and cooperate with the required clinical assessment and head MRI scan; 6) Native language is Mandarin Chinese, with an education level of primary school or above; 7) All participants are aware of the trial details, agree to participate in the trial, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Experiment 1: 1 Before the onset of the disease, other neurological and psychiatric disorders that might affect cognitive function and olfactory function occurred, such as Alzheimer's disease, Parkinson's disease, brain trauma, schizophrenia, etc. 2 There is a history of nasal or sinus diseases or surgeries, obstructive pulmonary diseases, or having caught a cold within 3 weeks. 3 There are contraindications for MRI examination (such as having a pacemaker implanted, having metal implants in the body, having claustrophobia, etc.). 4 There is a history of epilepsy and the use of anticonvulsant drugs. Experiment 2: 1) Before the onset of the disease, other neurological and psychiatric disorders that might affect cognitive function and olfactory function occurred, such as Alzheimer's disease, Parkinson's disease, brain trauma, schizophrenia, etc. 2) There is a history of nasal or sinus diseases or surgeries, obstructive pulmonary diseases, or having caught a cold within 3 weeks. 3) There is a history of allergic reactions to rose, eucalyptus, lemon or cinnamon odors. 4) There are contraindications for MRI examination (such as having a pacemaker installed, having metal implants in the body, having claustrophobia, etc.). 5) There is a history of epilepsy and the use of anticonvulsant drugs. Experiment 3: 1) Before the onset of the disease, other possible neurological and psychiatric disorders that could affect cognitive function and olfactory function occurred, such as Alzheimer's disease, Parkinson's disease, brain trauma, schizophrenia, etc. 2) There is a history of nasal or sinus diseases or surgeries, obstructive pulmonary diseases, or having caught a cold within 3 weeks. 3) There is a cranial bone defect. 4) There is a history of electroconvulsive therapy. 5) There are contraindications for MRI examination (such as having a pacemaker implanted, having metal implants inside the body, having claustrophobia, etc.). 6) There is a history of epilepsy and the use of anticonvulsant drugs.

Design outcomes

Primary

MeasureTime frame
Montreal cognitive assessment,MoCA;Sniffin’Sticks;rs-fMRI;

Secondary

MeasureTime frame
mini-mental state examination,MMSE;

Countries

China

Contacts

Public ContactPei Wang

Zhongda Hospital of Southeast University

wangpei0717@126.com+86 159 5175 2352

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026