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临床试验/CTRI/2023/03/050430
CTRI/2023/03/050430尚未招募2/3 期

IMMEDIATE EFFECT OF VISUAL YOGIC RESPIRATORY BIOFEEDBACK ON VISUOSPATIAL COGNITION AND CARDIAC INTEROCEPTION IN MIGRAINEURS: A RANDOMIZED CONTROLLED TRIAL

Dr Krithika A Ramaswamy1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年1月4日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Visuospatial Cognition

研究概览

简要总结

Migraine is a complex neurological condition that impacts a large proportion of the human population across all geographic locations and cultures. Current conventional management for migraine focuses more on headache relief. The clinical symptoms of migraine-related cognition are key evidence of functional brain abnormalities underlying migraine pathogenesis. Hence, improvement of cognitive function and interoception should be valued as therapeutic targets as they may aid in improving the quality of life and minimise loss of productivity in migraineurs.

The use of visual respiratory feedback may help hasten the learning process of the patient. At the same time, it also enables the treating yoga physician to objectively monitor the patient’s breathing pattern. Hence this study is undertaken to assess the efficacy of visual yogic respiratory biofeedback on visual and spatial memory and cardiac interoception in patients with migraine without aura.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • A score of ≥4 in the Migraine Screening Questionnaire (MS-Q)
  • Age between 18 to 60 years
  • History of migraine of at least 5 years
  • At least 12 migraine attacks in the last year
  • A score of ≤ 25 on the Montreal Cognitive Assessment (MoCA).

排除标准

  • Migraine with aura
  • Individuals with any other co-existing types of headaches
  • Other neurological diseases Presence of psychiatric co-morbidity
  • Consumption of psychotropic drugs, including migraine prophylactics
  • Consumption of caffeine or other stimulants 24 hours prior to the study.

结局指标

主要结局

Visuospatial Cognition

时间窗: Baseline and immediately after intervention

次要结局

  • Interoception(Baseline and immediately after intervention)

研究者

发起方
Dr Krithika A Ramaswamy
申办方类型
Other [self]

研究点 (1)

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