Remote Ischemic Preconditioning for Subcortical Vascular Dementia

NCT03022149 | Unknown

• 1 other identifier: IRB2016-YX-042
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subcortical Vascular Dementia

Outcome Measures

Primary Outcomes (7)

• 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

  Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.

  At the first day/sixth month after randomization

Secondary Outcomes (7)

• Serological inflammatory markers-hs-CRP

  At the fist day/sixth month after randomization

• Serological inflammatory markers-TNF-a

  At the fist day/sixth month after randomization

• Serological inflammatory markers-IL - 1b

  At the fist day/sixth month after randomization

• Serological inflammatory markers-IL - 6

  At the fist day/sixth month after randomization

• Serological inflammatory markers-ACT

  At the fist day/sixth month after randomization

Other Outcomes (5)

• 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

• Laboratory examination of the blood coagulation function

  At the first month/third month after randomization

Study Arms (2)

Doctormate® (200mmHg)

EXPERIMENTAL

Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months

Device: Doctormate® (200mmHg)

Doctormate® (60mmHg)

SHAM COMPARATOR

Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months

Device: Doctormate® (60mmHg)

Interventions

Doctormate® (200mmHg) DEVICE

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

Doctormate® (200mmHg)

Doctormate® (60mmHg) DEVICE

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

Doctormate® (60mmHg)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (1)

• 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.

  PMID: 31443692 DERIVED

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Junwei Hao, PHD, MD

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 16, 2017
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 16, 2017

Record last verified: 2017-01

Locations

CN (1)