- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05261243
EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain
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.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Paul T. Zebhauser, Dr.
- 전화번호: +49 89 4140 5938
- 이메일: paul.zebhauser@tum.de
연구 장소
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Bavaria
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München, Bavaria, 독일, 81675
- Department of Neurology, Center for Interdisciplinary Pain Medicine
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연락하다:
- Paul T. Zebhauser, Dr.
- 전화번호: +49 89 4140 5938
- 이메일: paul.zebhauser@tum.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Chronic pain condition
- Willing and able to sign informed consent for study participation
Exclusion Criteria:
- Severe concomitant neurological or psychiatric disease
- Primary headache condition
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PROMIS-29 Profile v2.1 (tablet-based)
기간: 1 year (1 assessment per participant)
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29 questions about neuropsychiatric symptoms and quality of life to be rated on a scale from 1-5; higher scores indicate more severe symptoms.
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1 year (1 assessment per participant)
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PROMIS-Adult v2.0 - Cognitive Function 4a (tablet-based)
기간: 1 year (1 assessment per participant)
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4 questions about subjective cognitive symptoms to be rated on a scale from 1-5; higher scores indicate more severe symptoms
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1 year (1 assessment per participant)
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Working memory task (tablet-based)
기간: 1 year (1 assessment per participant)
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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)
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1 year (1 assessment per participant)
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Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis
기간: 1 year (1 assessment per participant)
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Absolute and relative amplitudes/power (gamma, beta, alpha, theta)
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1 year (1 assessment per participant)
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Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Peak Frequency Analysis
기간: 1 year (1 assessment per participant)
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Maximum power value in the EEG frequency spectrum
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1 year (1 assessment per participant)
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Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Connectivity analysis
기간: 1 year (1 assessment per participant)
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Frequency specific connectivity (gamma, beta, alpha, theta)
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1 year (1 assessment per participant)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Markus Ploner, Prof. Dr., Department of Neurology, Klinikum rechts der Isar, Technical University of Munich
간행물 및 유용한 링크
일반 간행물
- Ploner M, Sorg C, Gross J. Brain Rhythms of Pain. Trends Cogn Sci. 2017 Feb;21(2):100-110. doi: 10.1016/j.tics.2016.12.001. Epub 2016 Dec 23.
- Higgins DM, Martin AM, Baker DG, Vasterling JJ, Risbrough V. The Relationship Between Chronic Pain and Neurocognitive Function: A Systematic Review. Clin J Pain. 2018 Mar;34(3):262-275. doi: 10.1097/AJP.0000000000000536.
- Dersh J, Polatin PB, Gatchel RJ. Chronic pain and psychopathology: research findings and theoretical considerations. Psychosom Med. 2002 Sep-Oct;64(5):773-86. doi: 10.1097/01.psy.0000024232.11538.54.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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