Subcortical Vascular DementiaRIPSVDNCT03022149
Remote Ischemic Preconditioning for Subcortical Vascular Dementia
A study testing Doctormate® (200mmHg) and Doctormate® (60mmHg) in people with Subcortical Vascular Dementia, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Subcortical Vascular Dementia
- What is being tested?
- Doctormate® (200mmHg) and Doctormate® (60mmHg)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jun 2017
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of vascular dementia
- In three months without cerebral infarction
- MMSE 15 to 26 points;CDR 1-2 points;MoCA < 26 points
- MRI showed subcortical ischemic cerebrovascular disease.
Who cannot join
- AD 、 FTD, DLB and other causes of dementia.
- Cortical/subcortical infarction
- Cortex watershed infarction
- Cerebral hemorrhage
- Hydrocephalus
- Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.
Show all 14Show fewer
- Cannot complete aphasia neuropsychological assessment.
- Genetic or inflammatory small vascular disease.
- Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.
- Alcohol poisoning;
- Cancer
- Hypothyroidism
- Schizophrenia;Hamilton depression rating scale > 17 points.
- Can not complete MRI.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
About this study
The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
Read the detailed description
In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. The participants had a diagnosis of subcortical vascular dementia at the neurology department of Tianjin medical university general hospital. Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. All participants received standard medical management.Participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. The remote ischemic precondition procedure was performed once daily over 180 consecutive days. Cognitive impairment assessment scale ( Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI diffusion tensor imaging, DTI were compared with the untreated control group.
- Conditions
- Subcortical Vascular Dementia
- Being tested
- Doctormate® (200mmHg), Doctormate® (60mmHg)
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctormate® (200mmHg)Device
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Doctormate® (60mmHg)Device
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Doctormate® (200mmHg) | Experimental | Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months Receives: Device: Doctormate® (200mmHg) |
| Doctormate® (60mmHg) | Sham comparator | Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months Receives: Device: Doctormate® (60mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment assessment scale-HVLT
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Measured: At the first day/sixth month after randomization
Cognitive impairment assessment scale-SDMT
Comparing two groups of participants score changes in-attention.
Measured: At the first day/sixth month after randomization
Cognitive impairment assessment scale-JLO
Comparing two groups of participants score changes in spatial perception and orientation ability.
Measured: At the first day/sixth month after randomization
Cognitive impairment assessment scale-ADL
Comparing two groups of participants score changes in daily life ability.
Measured: At the first day/sixth month after randomization
Cognitive impairment assessment scale-TMT
Comparing two groups of participants score changes in this test.This test reflects notice, order, mental flexibility, visual search and motor function, and set transfer (set shifting), at the same time reflect the hand-eye coordination, spatial perception and pay attention to ability.
Measured: At the first day/sixth month after randomization
Cognitive impairment assessment scale-NPI
Comparing two groups of participants score changes in mental behavior symptoms.
Measured: At the first day/sixth month after randomization
Cognitive impairment assessment scale-Chinese auditory learning test
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
Measured: At the first day/sixth month after randomization
Secondary outcomes (7)
Serological inflammatory markers-hs-CRP
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Measured: At the fist day/sixth month after randomization
Serological inflammatory markers-TNF-a
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Measured: At the fist day/sixth month after randomization
Serological inflammatory markers-IL - 1b
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Measured: At the fist day/sixth month after randomization
Serological inflammatory markers-IL - 6
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Measured: At the fist day/sixth month after randomization
Serological inflammatory markers-ACT
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Measured: At the fist day/sixth month after randomization
Imaging markers-DTI
To evaluate two groups of whole brain white matter (whole brain white matter, WBWM) and apparent normal white matter (normal appearing white matter, NAWM) difference of MD and FA before and after the treatment , to evaluate whether the treatment group more helpful to improve the neural axon damage.
Measured: At the fist day/sixth month after randomization
Imaging markers-Routine MRI
To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.
Measured: At the fist day/sixth month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subcortical Vascular DementiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junwei Hao, Tianjin Medical University General Hospital
- Investigators
- Junwei Hao, PHD, MD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022149
- Sponsor's protocol ID
- IRB2016-YX-042
- Acronym
- RIPSVD
- Status last verified
- Jan 2017
- First submitted
- 30 Dec 2016
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Liao Z, Bu Y, Li M, Han R, Zhang N, Hao J, Jiang W. Remote ischemic conditioning improves cognition in patients with subcortical ischemic vascular dementia. BMC Neurol. 2019 Aug 23;19(1):206. doi: 10.1186/s12883-019-1435-y.
PubMed 31443692
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning for Subcortical Vascular Dementia
- ClinicalTrials.gov ID
- NCT03022149
- Acronym / sponsor ID
- RIPSVD / IRB2016-YX-042
- Conditions
- Subcortical Vascular Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- 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 purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
Detailed description
In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. The participants had a diagnosis of subcortical vascular dementia at the neurology department of Tianjin medical university general hospital. Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. All participants received standard medical management.Participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. The remote ischemic precondition procedure was performed once daily over 180 consecutive days. Cognitive impairment assessment scale ( Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI diffusion tensor imaging, DTI were compared with the untreated control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doctormate® (200mmHg) | Experimental | Device: Doctormate® (200mmHg)Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months |
| Doctormate® (60mmHg) | Sham comparator | Device: Doctormate® (60mmHg)Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of vascular dementia
- In three months without cerebral infarction
- MMSE 15 to 26 points;CDR 1-2 points;MoCA < 26 points
- MRI showed subcortical ischemic cerebrovascular disease.
Key exclusion criteria (14 listed)
- AD 、 FTD, DLB and other causes of dementia.
- Cortical/subcortical infarction
- Cortex watershed infarction
- Cerebral hemorrhage
- Hydrocephalus
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 |
|---|---|---|
| Doctormate® (200mmHg)Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg. | Device | Doctormate® (200mmHg) |
| Doctormate® (60mmHg)Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg. | Device | Doctormate® (60mmHg) |
Primary outcome
Cognitive impairment assessment scale-HVLT
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Cognitive impairment assessment scale-SDMT
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in-attention.
Cognitive impairment assessment scale-JLO
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in spatial perception and orientation ability.
Cognitive impairment assessment scale-ADL
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in daily life ability.
Cognitive impairment assessment scale-TMT
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in this test.This test reflects notice, order, mental flexibility, visual search and motor function, and set transfer (set shifting), at the same time reflect the hand-eye coordination, spatial perception and pay attention to ability.
Cognitive impairment assessment scale-NPI
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in mental behavior symptoms.
Cognitive impairment assessment scale-Chinese auditory learning test
Time frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
7 secondary outcomes
Serological inflammatory markers-hs-CRP
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-TNF-a
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-IL - 1b
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-IL - 6
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-ACT
Time frame: At the fist day/sixth month after randomization
Imaging markers-DTI
Time frame: At the fist day/sixth month after randomization
Imaging markers-Routine MRI
Time frame: At the fist day/sixth month after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Derived from this study: PubMed 31443692Liao Z, Bu Y, Li M, Han R, Zhang N, Hao J, Jiang W. Remote ischemic conditioning improves cognition in patients with subcortical ischemic vascular dementia. BMC Neurol. 2019 Aug 23;19(1):206. doi: 10.1186/s12883-019-1435-y.
- Individual participant dataSharing planned: Undecided
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.
Junwei Hao, PHD, MD principal investigator
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doctormate® (200mmHg) and Doctormate® (60mmHg) in people with Subcortical Vascular Dementia, run by Tianjin Medical University General Hospital 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 4 inclusion and 14 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 16 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment assessment scale-HVLT (time frame: At the first day/sixth month after randomization). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022149, which also lists 1 linked publication.
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 16 Jan 2017; AzTrials last refreshed its copy on 29 Oct 2026.