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The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doctormate® (200mmHg) | Experimental | Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months |
|
| Doctormate® (60mmHg) | Sham Comparator | Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doctormate® (200mmHg) | Device | Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive impairment assessment scale-HVLT | Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies. | At the first day/sixth month after randomization |
| Cognitive impairment assessment scale-SDMT | Comparing two groups of participants score changes in-attention. | 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. | At the first day/sixth month after randomization |
| Cognitive impairment assessment scale-ADL | Comparing two groups of participants score changes in daily life ability. | 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. | At the first day/sixth month after randomization |
| Cognitive impairment assessment scale-NPI | Comparing two groups of participants score changes in mental behavior symptoms. | At the first day/sixth month after randomization |
| Cognitive impairment assessment scale-Chinese auditory learning test |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the fist day/sixth month after randomization |
| Serological inflammatory markers-TNF-a |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory examination of the urine routine | At the first month/third month after randomization | |
| Laboratory examination of the blood routine | At the first month/third month after randomization | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junwei Hao, PHD, MD | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31443692 | Derived | 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. |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Doctormate® (60mmHg) | Device | Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg. |
|
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge. |
| At the first day/sixth month after randomization |
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. |
| 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. | 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. | 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. | 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. | 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. | At the fist day/sixth month after randomization |
| Laboratory examination of the blood coagulation function |
| At the first month/third month after randomization |
| Laboratory examination of the liver function | At the first month/third month after randomization |
| Laboratory examination of the kidney function | At the first month/third month after randomization |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |