EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

Chronic Pain Clinical Trial

Official title:

EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05261243
• Other study ID #: 6/22 S-KH
• Status: Not yet recruiting
• Start date: February 2022
• Est. completion date: August 2023

Study information

• Verified date: February 2022
• Source: Technische Universität München
• Contact: Paul T. Zebhauser, Dr.
• Phone: +49 89 4140 5938
• Email: paul.zebhauser[@]tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Diagnostic Test:
• EEG / questionnaires / working memory task
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

Locations

Country	Name	City	State
Germany	Department of Neurology, Center for Interdisciplinary Pain Medicine	München	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Dersh J, Polatin PB, Gatchel RJ. Chronic pain and psychopathology: research findings and theoretical considerations. Psychosom Med. 2002 Sep-Oct;64(5):773-86. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)