- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05261243
EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Paul T. Zebhauser, Dr.
- Telefonnummer: +49 89 4140 5938
- E-mail: paul.zebhauser@tum.de
Studiesteder
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Bavaria
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München, Bavaria, Tyskland, 81675
- Department of Neurology, Center for Interdisciplinary Pain Medicine
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Kontakt:
- Paul T. Zebhauser, Dr.
- Telefonnummer: +49 89 4140 5938
- E-mail: paul.zebhauser@tum.de
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
PROMIS-29 Profile v2.1 (tablet-based)
Tidsramme: 1 year (1 assessment per participant)
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29 questions about neuropsychiatric symptoms and quality of life to be rated on a scale from 1-5; higher scores indicate more severe symptoms.
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1 year (1 assessment per participant)
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PROMIS-Adult v2.0 - Cognitive Function 4a (tablet-based)
Tidsramme: 1 year (1 assessment per participant)
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4 questions about subjective cognitive symptoms to be rated on a scale from 1-5; higher scores indicate more severe symptoms
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1 year (1 assessment per participant)
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Working memory task (tablet-based)
Tidsramme: 1 year (1 assessment per participant)
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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)
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Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Power Analysis
Tidsramme: 1 year (1 assessment per participant)
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Absolute and relative amplitudes/power (gamma, beta, alpha, theta)
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1 year (1 assessment per participant)
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Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Peak Frequency Analysis
Tidsramme: 1 year (1 assessment per participant)
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Maximum power value in the EEG frequency spectrum
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1 year (1 assessment per participant)
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Quantitative resting-state Electroencephalography (5 minute EEG via 29 scalp electrodes): Connectivity analysis
Tidsramme: 1 year (1 assessment per participant)
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Frequency specific connectivity (gamma, beta, alpha, theta)
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1 year (1 assessment per participant)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Markus Ploner, Prof. Dr., Department of Neurology, Klinikum rechts der Isar, Technical University of Munich
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6/22 S-KH
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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