Cognitive ImpairmentNCT05930249
Effect of a fNIRS-based Personalized Multi-domain Intervention on Cognitive in Elderly Population With High Risk of Stroke
A study testing Personalized multidomain intervention in people with Cognitive Impairment and Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This functional near-infrared spectroscopy-based personalized multidomain intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 years old persons with high risk of stroke in China. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Stroke, Dementia
- What is being tested?
- Personalized multidomain intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 45-74 years
- high risk of stroke (with≥3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
Who cannot join
- previously diagnosed dementia
- previously diagnosed stroke (both cerebral infarction and hemorrhage)
- suspected dementia after clinical assessment by study physician at screening visit
- Mini-mental State Examination [MMSE] score<20
- disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularization within 1 year previously)
- severe loss of vision, hearing, or communicative ability
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- disorders preventing cooperation as judged by the study physician
- coincident participation in another intervention trial
- any MRI contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
Min Lou
Hangzhou, Zhejiang, 310000
Zexin Chen, 13757118366, HREC2013@126.com
About this study
This functional near-infrared spectroscopy-based personalized multidomain intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 years old persons with high risk of stroke in China. The primary outcome is 6-months change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on functional near-infrared spectroscopy will prevent cognitive decline by the initial 6-months intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 2 years' follow-up. The investigators hypothesize that the functional near-infrared spectroscopy-based personalized intervention may reduce the 2-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, social activity, and cognitive training activities.
Read the detailed description
Patients with ≥ 3 stroke risk factors (including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke), or with transient ischemic attack, are regarded as patients with high risk of stroke. Studies have indicated that these stroke risk factors might be associated with an increased risk of cerebral small vessel disease (CSVD) progress, glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However, prevention in these patients is largely unknown and the management of these patients is a very troublesome issue. Management on those patients mainly focused on improving lifestyle. Recently, cognitive training has emerged, with change from strategy-oriented paper-and-pencil and instructional training methods to computer-aided cognitive training that is difficulty adaptive and focuses on ability improvement. Studies have shown that the functional state of the brain is more sensitive and specific than the behavioral performance, so it provides a theoretical basis for personalized intervention. Functional near-infrared spectroscopy imaging converts signal values into oxygenated hemoglobin, deoxyhemoglobin, and changes in overall hemoglobin concentration according to Beer-Lambert's law to reflect brain activity levels, which is more convenient than EEG and functional magnetic resonance in collecting task-state signal. By pre-analyzing the correlation between the activation level of each brain region and cognition, the brain area related to cognitive function under each task can be preliminarily obtained, and the patient can be further judged whether the patient needs to be trained for the task according to the activity level of the brain region to achieve the purpose of personalization. The investigators hypothesize that the intervention based on functional near-infrared spectroscopy imaging will reduce cognitive impairment, CSVD progress, and reduce dementia and cerebrovascular events incidence in the study group compared to the control group.
- Conditions
- Cognitive Impairment, Stroke, Dementia
- Being tested
- Personalized multidomain intervention
- Medical subject headings
- Cognitive Dysfunction, Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized multidomain interventionBehavioural
- Patients will complete personalized cognitive training based on baseline fNIRS on APP (20-30 mins/day, 3-4 days/week, 6 months).
- Shared decision-making on risk factor of stroke between doctors and patients
- Social support by grouping patients online to ensure close interaction with other patients in the same arm
| Study group | Role | What they receive |
|---|---|---|
| Standard health counseling | No intervention | Not described |
| Personalized multidomain intervention | Experimental | Not described Receives: Behavioral: Personalized multidomain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Primary Outcome
Measured: 6 months
Secondary outcomes (18)
Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition
short-term secondary outcome
Measured: 6 months
Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition
long-term secondary outcome
Measured: 2 year
Cognitive function change assessed by Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
short-term secondary outcome
Measured: 6 months
Cognitive function change assessed by Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
long-term secondary outcome
Measured: 2 year
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
short-term secondary outcome
Measured: 6 months
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
long-term secondary outcome
Measured: 2 year
Signal change of resting-state functional near-infrared spectroscopy
short-term secondary outcome
Measured: 6 months
Signal change of resting-state functional near-infrared spectroscopy
long-term secondary outcome
Measured: 2 year
Activation changes of task functional near-infrared spectroscopy
short-term secondary outcome
Measured: 6 months
Activation changes of task functional near-infrared spectroscopy
long-term secondary outcome
Measured: 2 year
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
short-term secondary outcome
Measured: 6 months
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
long-term secondary outcome
Measured: 2 year
Changes in functional network-related characteristics assessed by fMRI, including intra- and inter-network connectivity, graph theory, and dynamic functional connectivity
short-term secondary outcome
Measured: 6 months
Changes in functional network-related characteristics assessed by fMRI, including intra- and inter-network connectivity, graph theory, and dynamic functional connectivity
long-term secondary outcome
Measured: 2 year
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
short-term secondary outcome
Measured: 6 months
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
long-term secondary outcome
Measured: 2 year
Changes in metabolite composition to measure the change of metabolite profiles in participants' faecal samples and serum samples
short-term secondary outcome; metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)
Measured: 6 months
Changes in metabolite composition to measure the change of metabolite profiles in participants' faecal samples and serum samples
long-term secondary outcome; metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930249
- Sponsor's protocol ID
- FNIRS
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a fNIRS-based Personalized Multi-domain Intervention on Cognitive in Elderly Population With High Risk of Stroke
- ClinicalTrials.gov ID
- NCT05930249
- Acronym / sponsor ID
- FNIRS
- Conditions
- Cognitive Impairment, Stroke, Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Jul 2023 (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.
This functional near-infrared spectroscopy-based personalized multidomain intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 years old persons with high risk of stroke in China. The primary outcome is 6-months change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on functional near-infrared spectroscopy will prevent cognitive decline by the initial 6-months intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 2 years' follow-up. The investigators hypothesize that the functional near-infrared spectroscopy-based personalized intervention may reduce the 2-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, social activity, and cognitive training activities.
Detailed description
Patients with ≥ 3 stroke risk factors (including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke), or with transient ischemic attack, are regarded as patients with high risk of stroke. Studies have indicated that these stroke risk factors might be associated with an increased risk of cerebral small vessel disease (CSVD) progress, glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However, prevention in these patients is largely unknown and the management of these patients is a very troublesome issue. Management on those patients mainly focused on improving lifestyle. Recently, cognitive training has emerged, with change from strategy-oriented paper-and-pencil and instructional training methods to computer-aided cognitive training that is difficulty adaptive and focuses on ability improvement. Studies have shown that the functional state of the brain is more sensitive and specific than the behavioral performance, so it provides a theoretical basis for personalized intervention. Functional near-infrared spectroscopy imaging converts signal values into oxygenated hemoglobin, deoxyhemoglobin, and changes in overall hemoglobin concentration according to Beer-Lambert's law to reflect brain activity levels, which is more convenient than EEG and functional magnetic resonance in collecting task-state signal. By pre-analyzing the correlation between the activation level of each brain region and cognition, the brain area related to cognitive function under each task can be preliminarily obtained, and the patient can be further judged whether the patient needs to be trained for the task according to the activity level of the brain region to achieve the purpose of personalization. The investigators hypothesize that the intervention based on functional near-infrared spectroscopy imaging will reduce cognitive impairment, CSVD progress, and reduce dementia and cerebrovascular events incidence in the study group compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard health counseling | No intervention | – |
| Personalized multidomain intervention | Experimental | Behavioral: Personalized multidomain intervention |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 45-74 years
- high risk of stroke (with≥3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
Key exclusion criteria (9 listed)
- previously diagnosed dementia
- previously diagnosed stroke (both cerebral infarction and hemorrhage)
- suspected dementia after clinical assessment by study physician at screening visit
- Mini-mental State Examination [MMSE] score<20
- disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularization within 1 year previously)
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 |
|---|---|---|
| Personalized multidomain intervention1. Patients will complete personalized cognitive training based on baseline fNIRS on APP (20-30 mins/day, 3-4 days/week, 6 months). 2. Shared decision-making on risk factor of stroke between doctors and patients 3. Social support by grouping patients online to ensure close interaction with other patients in the same arm | Behavioural | Personalized multidomain intervention |
Primary outcome
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Time frame: 6 months
Primary Outcome
18 secondary outcomes
Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition
Time frame: 6 months
Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition
Time frame: 2 year
Cognitive function change assessed by Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 6 months
Cognitive function change assessed by Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 2 year
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 6 months
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 2 year
Signal change of resting-state functional near-infrared spectroscopy
Time frame: 6 months
Signal change of resting-state functional near-infrared spectroscopy
Time frame: 2 year
Activation changes of task functional near-infrared spectroscopy
Time frame: 6 months
Activation changes of task functional near-infrared spectroscopy
Time frame: 2 year
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Time frame: 6 months
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Time frame: 2 year
Changes in functional network-related characteristics assessed by fMRI, including intra- and inter-network connectivity, graph theory, and dynamic functional connectivity
Time frame: 6 months
Changes in functional network-related characteristics assessed by fMRI, including intra- and inter-network connectivity, graph theory, and dynamic functional connectivity
Time frame: 2 year
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Time frame: 6 months
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Time frame: 2 year
Changes in metabolite composition to measure the change of metabolite profiles in participants' faecal samples and serum samples
Time frame: 6 months
Changes in metabolite composition to measure the change of metabolite profiles in participants' faecal samples and serum samples
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized multidomain intervention in people with Cognitive Impairment and Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Jul 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol (time frame: 6 months). 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 5 Jul 2023.