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Chronic PainNCT05261243

EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

An observational study of Chronic Pain, run by Technical University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
EEG / questionnaires / working memory task
How many people
150 participants
Where
1 siteGermany
Study dates
Feb 2022to Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Severe concomitant neurological or psychiatric disease
  • Primary headache condition

Trial locations and contacts

1 site in 1 country.

Paul T. Zebhauser, Dr. contact

+49 89 4140 5938

paul.zebhauser@tum.de

Germany1 site

  • Department of Neurology, Center for Interdisciplinary Pain Medicine

    München, Bavaria, 81675

    Paul T. Zebhauser, Dr., +49 89 4140 5938, paul.zebhauser@tum.de

Other trials in Germany

About this study

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.

Read more

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
Being tested
EEG / questionnaires / working memory task
Keywords
Chronic pain, electroencephalography, neuropsychiatry, working memory
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEG / questionnaires / working memory taskDiagnostic 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year (1 assessment per participant)

  2. 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

    Measured: 1 year (1 assessment per participant)

  3. 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)

    Measured: 1 year (1 assessment per participant)

  4. Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis

    Absolute and relative amplitudes/power (gamma, beta, alpha, theta)

    Measured: 1 year (1 assessment per participant)

  5. Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Peak Frequency Analysis

    Maximum power value in the EEG frequency spectrum

    Measured: 1 year (1 assessment per participant)

  6. Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Connectivity analysis

    Frequency specific connectivity (gamma, beta, alpha, theta)

    Measured: 1 year (1 assessment per participant)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study startFeb 2022 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05261243
Sponsor's protocol ID
6/22 S-KH
Status last verified
Feb 2022
First submitted
8 Feb 2022
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will make anonymized data publicly available on data sharing platforms like the Open Science Framework (https://osf.io/)

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.

    PubMed 28025007

  • 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.

    PubMed 28719507

  • 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.

    PubMed 12271108

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paul T. Zebhauser, Dr. (+49 89 4140 5938, paul.zebhauser@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS-29 Profile v2.1 (tablet-based) (time frame: 1 year (1 assessment per participant)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05261243, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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