EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

NCT05261243 | Unknown

• 1 other identifier: 6/22 S-KH
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; electroencephalography; neuropsychiatry; working memory

Outcome Measures

Primary Outcomes (6)

• 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)

Interventions

EEG / questionnaires / working memory task DIAGNOSTIC_TEST

EEG resting state measurements and analysis of frequency bands (gamma, beta, alpha, theta), peak frequencies and connectivity measures / questionnaires for depression, anxiety, social activities, cognition, pain, sleep, fatigue / digitalized block-tapping task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Severe concomitant neurological or psychiatric disease
• Primary headache condition

Sponsors & Collaborators

• Technical University of Munich: lead
• German Research Foundation: collaborator

Study Sites (1)

Department of Neurology, Center for Interdisciplinary Pain Medicine

München, Bavaria, 81675, Germany

Location

Related Publications (3)

• 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.

  PMID: 28025007 BACKGROUND

• 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.

  PMID: 28719507 BACKGROUND

• 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.

  PMID: 12271108 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Markus Ploner, Prof. Dr.

  Department of Neurology, Klinikum rechts der Isar, Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul T. Zebhauser, Dr.

CONTACT

+49 89 4140 5938; paul.zebhauser@tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 2, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After publication

Locations

DE (1)