Intra- and Inter-individual Differences of Pain

NCT ID: NCT05616091

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-12-15

Brief Summary

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Pain is a highly subjective and variable phenomenon. Different persons perceive objectively identical nociceptive stimuli differently. Moreover, the same person may perceive objectively identical stimuli differently in different situations, or even from one moment to another. In the brain, the processing of pain is associated with different neuronal responses originating from an extended network of brain areas. These responses include evoked activity as well as neuronal oscillations at alpha (8-13 Hz), beta (14-30 Hz) and gamma (30-100 Hz) frequencies. All these responses covary with moment-to-moment variations of pain within subjects (intra-subject variability). However, only the gamma response correlates with variations of pain between subjects (inter-subject variability). To date, it has remained unknown whether these relationships remain stable and reproducible across longer periods of time (inter-session-variability). Thus, the current project aims to systematically characterize how different pain-associated brain responses encode intra-individual, inter-individual, and inter-session variations of pain perception. To this end, the investigators will record pain-associated brain responses of 155 healthy participants at two different points in time. Each time, short painful stimuli will be applied to the participants' hand and they will be asked to verbally rate the perceived pain intensity, while pain-associated brain responses will be recorded using electroencephalography (EEG). This will allow to investigate the relationships between pain-associated brain responses and intra-individual and inter-individual variations of pain and to compare these measures and their relationships between sessions. In order to quantify the influence of demographic and psychological factors, i.e. age, mood and sleep quality / quantity on pain variability, established questionnaires will be used. In order to compare the functional significance of brain responses to other pain-associated neuronal responses, pain-associated responses of the autonomic system will be recorded and related to pain variability. Results of the project promise to elucidate the neuronal mechanisms underlying intra-individual, inter-individual and inter-session variability of pain. Such knowledge provides the basis for the development of a biomarker for pain, which might reasonably complement the self-assessment of pain. Moreover, as pain perception and objective stimulation tend to dissociate in pathological pain, the current project promises insights into the neuronal mechanisms of chronic pain.

Detailed Description

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Conditions

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Experimental Pain in Healthy Human Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each participant will participate in two identical experimental sessions. Sessions will be separated from each other by one month. During each session, participants will undergo an experimental paradigm of about 15 min duration. In this paradigm, 80 experimental painful stimuli of different intensities will be applied using a laser device (DEKA Stimul 1340, Calenzano, Italy). Participants will be asked to verbally rate the intensity of every stimulus on a scale ranging from 0 ('no pain') to 100 ('maximally tolerable pain'). At the same time, brain responses will be recorded by using electroencephalography (EEG). Autonomic responses will be operationalized by the recording of skin conductance responses (SCRs).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not be informed about the intensities of the nociceptive stimuli administered during the experimental paradigm.

Interventions

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painful stimulation by using a laser device (DEKA Stimul 1340, Calenzano, Italy)

In each of the two sessions, 80 experimental painful stimuli of different intensities (2.5 J, 3 J, 3.5 J, 4 J) will be applied using the laser device listed above.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged 18 years or above
* Right-handedness
* Written informed consent

Exclusion Criteria

* Pregnancy
* Neurological or psychiatric diseases (e.g. epilepsy, stroke, depression, anxiety disorders)
* Severe general illnesses (e.g. tumors, diabetes)
* Skin diseases (e.g. dermatitis, psoriasis or eczema)
* Current or recurrent pain
* (Regular) intake of centrally acting, antibiotic or analgesic medication
* Surgical procedures involving the brain or spinal cord
* Head trauma followed by impairment of consciousness
* Past fainting spells or syncopes
* Side-effects following previous electrical or magnetic stimulation
* Side-effects following previous thermal stimulation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Markus Ploner

Professor of Human Pain Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Ploner, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Locations

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

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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May ES, Tiemann L, Gil Avila C, Bott FS, Hohn VD, Gross J, Ploner M. Assessing the predictive value of peak alpha frequency for the sensitivity to pain. Pain. 2025 Mar 11;166(9):2076-2090. doi: 10.1097/j.pain.0000000000003571.

Reference Type DERIVED
PMID: 40085759 (View on PubMed)

Other Identifiers

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11/2019

Identifier Type: -

Identifier Source: org_study_id

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