EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

February 18, 2022 updated by: Technical University of Munich

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 Profile v2.1 (tablet-based) Time Frame: 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.	1 year (1 assessment per participant)
PROMIS-Adult v2.0 - Cognitive Function 4a (tablet-based) Time Frame: 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	1 year (1 assessment per participant)
Working memory task (tablet-based) Time Frame: 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)	1 year (1 assessment per participant)
Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis Time Frame: 1 year (1 assessment per participant)	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 Time Frame: 1 year (1 assessment per participant)	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 Time Frame: 1 year (1 assessment per participant)	Frequency specific connectivity (gamma, beta, alpha, theta)	1 year (1 assessment per participant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)