NCT03022149

Remote Ischemic Preconditioning for Subcortical Vascular Dementia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Doctormate® (200mmHg)	Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
DEVICE	Doctormate® (60mmHg)	Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2017-01-16
• Last updated: 2017-01-16

Locations

1 site across 1 country: China