Clinical trial NCT05261243: EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain
Official title: EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Chronic pain
electroencephalography
neuropsychiatry
working memory
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2022-03-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All chronic pain patients eligible according to the inclusion and exclusion criteria described above treated at the Center for Interdisciplinary Pain Medicine at the Technical University of Munich are invited to voluntarily participate in the study.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: PROMIS-29 Profile v2.1 (tablet-based)
timeFrame: 1 year (1 assessment per participant)
measure: PROMIS-Adult v2.0 - Cognitive Function 4a (tablet-based)
timeFrame: 1 year (1 assessment per participant)
measure: Working memory task (tablet-based)
timeFrame: 1 year (1 assessment per participant)
measure: Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis
timeFrame: 1 year (1 assessment per participant)
measure: Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Peak Frequency Analysis
timeFrame: 1 year (1 assessment per participant)
measure: Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Connectivity analysis
timeFrame: 1 year (1 assessment per participant)
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of Neurology, Center for Interdisciplinary Pain Medicine
state: Bavaria
Study officials:
affiliation: Department of Neurology, Klinikum rechts der Isar, Technical University of Munich
name: Markus Ploner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.