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Clinical Trials/NCT05261243
NCT05261243
Unknown
Not Applicable

EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

Technical University of Munich1 site in 1 country150 target enrollmentFebruary 2022
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Technical University of Munich
Enrollment
150
Locations
1
Primary Endpoint
PROMIS-29 Profile v2.1 (tablet-based)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2022
End Date
August 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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

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)

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)

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

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)

Study Sites (1)

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