Remote Ischemic Preconditioning for Subcortical Vascular Dementia

Subcortical Vascular Dementia Clinical Trial

— RIPSVD  

Official title:

Remote Ischemic Preconditioning for Subcortical Vascular Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03022149
• Other study ID #: IRB2016-YX-042
• Status: Active, not recruiting
• Phase: N/A
• First received: December 30, 2016
• Last updated: January 12, 2017
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2017
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of vascular dementia

2. In three months without cerebral infarction

3. MMSE 15 to 26 points;CDR 1-2 points;MoCA < 26 points

4. MRI showed subcortical ischemic cerebrovascular disease.

Exclusion Criteria:

1. AD ? FTD, DLB and other causes of dementia.

2. Cortical/subcortical infarction

3. Cortex watershed infarction

4. Cerebral hemorrhage

5. Hydrocephalus

6. Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.

7. Cannot complete aphasia neuropsychological assessment.

8. Genetic or inflammatory small vascular disease.

9. Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.

10. Alcohol poisoning;

11. Cancer

12. Hypothyroidism

13. Schizophrenia;Hamilton depression rating scale > 17 points.

14. Can not complete MRI.

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Subcortical Vascular Dementia

Intervention

Device:
• Doctormate® (200mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
• Doctormate® (60mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Laboratory examination of the urine routine		At the first month/third month after randomization
Other	Laboratory examination of the blood routine		At the first month/third month after randomization
Other	Laboratory examination of the blood coagulation function		At the first month/third month after randomization
Other	Laboratory examination of the liver function		At the first month/third month after randomization
Other	Laboratory examination of the kidney function		At the first month/third month after randomization
Primary	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
Primary	Cognitive impairment assessment scale-SDMT	Comparing two groups of participants score changes in-attention.	At the first day/sixth month after randomization
Primary	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
Primary	Cognitive impairment assessment scale-ADL	Comparing two groups of participants score changes in daily life ability.	At the first day/sixth month after randomization
Primary	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
Primary	Cognitive impairment assessment scale-NPI	Comparing two groups of participants score changes in mental behavior symptoms.	At the first day/sixth month after randomization
Primary	Cognitive impairment assessment scale-Chinese auditory learning test	Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.	At the first day/sixth month after randomization
Secondary	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
Secondary	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.	At the fist day/sixth month after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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