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临床试验/NCT05261243
NCT05261243Unknown不适用

EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
PROMIS-29 Profile v2.1 (tablet-based)

研究概览

简要总结

Chronic pain is a challenge for patients, physicians and society due to its high prevalence and its substantial individual and socio-economic burden.

In recent years, innovative EEG-techniques have been used to study rhythmic brain activities in a variety of neuropsychiatric populations and in chronic pain and various abnormalities in neuronal oscillation patterns and connectivity between brain regions have been observed. However, it remains unclear whether these alterations of brain activity in chronic pain patients reflect pain characteristics like intensity, duration or type (e.g. neuropathic pain), or whether they reflect other symptoms associated with chronic pain.

Neuropsychiatric comorbidities and cognitive deficits of chronic pain are being increasingly recognized, as they frequently cause substantial problems in social life and hinder patients from being able to work. However, it has not been studied yet whether neuronal oscillations and connectivity patterns in the brains of chronic pain patients covary with neuropsychiatric comorbidities (e.g. depression, anxiety, fatigue) and cognitive functioning.

To this end, the investigators will obtain resting state EEG data in large cohort of patients with chronic pain and assess clinical characteristics of chronic pain including a variety of neuropsychiatric symptoms as well as working memory capacity as a proxy for cognitive functioning.

Results from this study will offer valuable insights into and a better understanding of brain dysfunction of patients suffering from chronic pain. This can be helpful for diagnostic and therapeutic advances (e.g. brain stimulation and neurofeedback methods) in the near future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain condition
  • Willing and able to sign informed consent for study participation

排除标准

  • Severe concomitant neurological or psychiatric disease
  • Primary headache condition

结局指标

主要结局

PROMIS-29 Profile v2.1 (tablet-based)

时间窗: 1 year (1 assessment per participant)

29 questions about neuropsychiatric symptoms and quality of life to be rated on a scale from 1-5; higher scores indicate more severe symptoms.

PROMIS-Adult v2.0 - Cognitive Function 4a (tablet-based)

时间窗: 1 year (1 assessment per participant)

4 questions about subjective cognitive symptoms to be rated on a scale from 1-5; higher scores indicate more severe symptoms

Working memory task (tablet-based)

时间窗: 1 year (1 assessment per participant)

Digitalized self-developed block-tapping task; summarized number of correctly answered levels results in final score (minium 0, maximum 14 points; higher scores indicating higher working memory capacity)

Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis

时间窗: 1 year (1 assessment per participant)

Absolute and relative amplitudes/power (gamma, beta, alpha, theta)

Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Peak Frequency Analysis

时间窗: 1 year (1 assessment per participant)

Maximum power value in the EEG frequency spectrum

Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Connectivity analysis

时间窗: 1 year (1 assessment per participant)

Frequency specific connectivity (gamma, beta, alpha, theta)

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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