Experimental Pain in Healthy Human SubjectsNCT05616091
Intra- and Inter-individual Differences of Pain
A study testing painful stimulation by using a laser device (DEKA Stimul 1340, Calenzano, Italy) in people with Experimental Pain in Healthy Human Subjects, run by Technical University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Experimental Pain in Healthy Human Subjects
- What is being tested?
- painful stimulation by using a laser device (DEKA Stimul 1340, Calenzano, Italy)
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- 1 siteGermany
- Study dates
- 10 Dec 2019to 15 Dec 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or above
- Right-handedness
- Written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Klinikum rechts der Isar, Technical University of Munich
Munich, Bavaria, 81675
About this study
Official title: Brain Mechanisms of Intra- and Inter-individual Differences in the Perception of Pain
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.
- Being tested
- painful stimulation by using a laser device (DEKA Stimul 1340, Calenzano, Italy)
- Keywords
- pain, variability, intra-individual, inter-individual, inter-session, electroencephalography, laser-evoked potentials, neuronal oscillations, alpha, gamma, brain, EEG
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painful stimulation by using a laser device (DEKA Stimul 1340, Calenzano, Italy)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal pain rating (NRS; 0: 'no pain' to 100: 'maximal tolerable pain')
Eighty painful stimuli will be applied to the participants' left hand. Participants will be instructed to verbally rate the perceived pain intensity of each stimulus on a numerical rating scale (see above).
Measured: During procedure (15 min experimental paradigm in each session)
Pain-associated brain responses
A 64-channel electroencephalogram (EEG) will be recorded. In offline analyses, Laser-evoked potentials (LEPs) will be quantified with regard to amplitudes and latencies. In addition, power of oscillatory brain activity will be quantified in the alpha (8-13 Hz), beta (14-30 Hz) and gamma (30-100 Hz) frequency bands.
Measured: During procedure (15 min experimental paradigm in each session)
Secondary outcomes (6)
skin conductance response (µS)
Skin conductance responses will be recorded using two electrodes attached to the index and middle finger of the left hand.
Measured: During procedure (15 min experimental paradigm in each session)
Customized protocol
Demographic and psychological factors which might potentially influence the intra- and inter-individual variability of pain perception will be quantified at the beginning of each session using established and customized questionnaires. These include a customized protocol quantifying the alcohol-, nicotine- and caffeine-consumption, the sleep quality during the previous night as well as, in case of female participants, the day of the menstrual cycle.
Measured: At the beginning of each session
German version of the Pittsburgh Sleep Quality Index (PSQI)
The German version of the established Pittsburgh Sleep Quality Index will be included to quantify the sleep quality during the previous four weeks. The PSQI comprises a total of 18 items which are assigned to seven components. The total score results from the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to reduced sleep quality.
Measured: At the beginning of each session
German version of the Hospital Anxiety and Depression Scale (HADS)
The German version of the Hospital Anxiety and Depression Scale will be included to quantify levels of anxiety and depression. The HADS comprises 14 items of which seven are assigned to the anxiety- and the other seven to the depression-subscale. The score ranges from 0 - 21 for each subscale, with a higher score corresponding to higher levels of anxiety or depression, respectively.
Measured: At the beginning of each session
German version of the Positive and Negative Affect Scale (PANAS)
The German version of the Positive and Negative Affect Scale will be included to quantify momentary levels of positive and negative affect. The PANAS comprises 20 items of which 10 are assigned to the dimension positive or negative affect, respectively. The score ranges from 0 - 50 for each dimension, with a higher score corresponding to higher levels of positive or negative affect, respectively.
Measured: At the beginning of each session
German version of the Pain Sensitivity Questionnaire (PSQ)
The German version of the Pain Sensitivity Questionnaire will be included to quantify individual pain sensitivity. The PSQ comprises 17 items. The total score ranges from 0 - 170, with a higher score corresponding to higher individual pain sensitivity.
Measured: At the beginning of each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start10 Dec 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Experimental Pain in Healthy Human SubjectsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Markus Ploner, Technical University of Munich
- Investigators
- Markus Ploner, Prof. Dr. med., Principal investigator, Department of Neurology, Klinikum rechts der Isar, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616091
- Sponsor's protocol ID
- 11/2019
- Status last verified
- Jan 2023
- First submitted
- 7 Nov 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized individual participant data sets will be made available at the OSF online repository \[https://osf.io/\] upon publication.
Publications
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.
PubMed 40085759
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Intra- and Inter-individual Differences in the Perception of Pain
- ClinicalTrials.gov ID
- NCT05616091
- Acronym / sponsor ID
- 11/2019
- Keywords
- pain, variability, intra-individual, inter-individual, inter-session, electroencephalography, laser-evoked potentials, neuronal oscillations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Model description
- 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).
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or above
- Right-handedness
- Written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Verbal pain rating (NRS; 0: 'no pain' to 100: 'maximal tolerable pain')
Time frame: During procedure (15 min experimental paradigm in each session)
Eighty painful stimuli will be applied to the participants' left hand. Participants will be instructed to verbally rate the perceived pain intensity of each stimulus on a numerical rating scale (see above).
Pain-associated brain responses
Time frame: During procedure (15 min experimental paradigm in each session)
A 64-channel electroencephalogram (EEG) will be recorded. In offline analyses, Laser-evoked potentials (LEPs) will be quantified with regard to amplitudes and latencies. In addition, power of oscillatory brain activity will be quantified in the alpha (8-13 Hz), beta (14-30 Hz) and gamma (30-100 Hz) frequency bands.
6 secondary outcomes
skin conductance response (µS)
Time frame: During procedure (15 min experimental paradigm in each session)
Customized protocol
Time frame: At the beginning of each session
German version of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: At the beginning of each session
German version of the Hospital Anxiety and Depression Scale (HADS)
Time frame: At the beginning of each session
German version of the Positive and Negative Affect Scale (PANAS)
Time frame: At the beginning of each session
German version of the Pain Sensitivity Questionnaire (PSQ)
Time frame: At the beginning of each session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 40085759May 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.
- Individual participant dataSharing planned: Yes. Pseudonymized individual participant data sets will be made available at the OSF online repository [https://osf.io/] upon publication.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Ploner, Prof. Dr. med. principal investigator
Department of Neurology, Klinikum rechts der Isar, Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing painful stimulation by using a laser device (DEKA Stimul 1340, Calenzano, Italy) in people with Experimental Pain in Healthy Human Subjects, 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 25 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal pain rating (NRS; 0: 'no pain' to 100: 'maximal tolerable pain') (time frame: During procedure (15 min experimental paradigm in each session)). The study lists 2 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 NCT05616091, which also lists 1 linked publication.
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 25 Jan 2023.