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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Diagnostic test: EEG / questionnaires / working memory task

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Paul T. Zebhauser, Dr.; Phone Number: +49 89 4140 5938; Email: paul.zebhauser@tum.de

Study Locations

• Germany
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Department of Neurology, Center for Interdisciplinary Pain Medicine
      • Contact: Paul T. Zebhauser, Dr.; Phone Number: +49 89 4140 5938; Email: paul.zebhauser@tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 Profile v2.1 (tablet-based)	29 questions about neuropsychiatric symptoms and quality of life to be rated on a scale from 1-5; higher scores indicate more severe symptoms.	1 year (1 assessment per participant)
PROMIS-Adult v2.0 - Cognitive Function 4a (tablet-based)	4 questions about subjective cognitive symptoms to be rated on a scale from 1-5; higher scores indicate more severe symptoms	1 year (1 assessment per participant)
Working memory task (tablet-based)	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)	1 year (1 assessment per participant)
Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis	Absolute and relative amplitudes/power (gamma, beta, alpha, theta)	1 year (1 assessment per participant)
Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Peak Frequency Analysis	Maximum power value in the EEG frequency spectrum	1 year (1 assessment per participant)
Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Connectivity analysis	Frequency specific connectivity (gamma, beta, alpha, theta)	1 year (1 assessment per participant)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Markus Ploner, Prof. Dr., Department of Neurology, Klinikum rechts der Isar, Technical University of Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Chronic pain; electroencephalography; working memory; neuropsychiatry
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 6/22 S-KH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make anonymized data publicly available on data sharing platforms like the Open Science Framework (https://osf.io/)
• IPD Sharing Time Frame: After publication
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No