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NCT04296968
Sensory Evidence and Expectations in Pain Processing
NA trial testing Painful stimulation using a laser device (DEKA Stimul 1340, Calenzano, Italy) in Experimental Pain in Healthy Human Participants in 50 participants. Completed in 1 December 2020.
1 December 2020
Quick facts
| Lead sponsor | Technical University of Munich |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 50 |
| Start date | 1 March 2020 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Painful stimulation using a laser device (DEKA Stimul 1340, Calenzano, Italy)
- Visual cueing
Conditions studied
- Experimental Pain in Healthy Human Participants — all drugs for Experimental Pain in Healthy Human Participants →
Sponsor
Technical University of Munich
Who can join
Adults 18 to 65, any sex, with Experimental Pain in Healthy Human Participants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pain is a highly complex and subjective phenomenon which is not only rooted in sensory information but also shaped by cognitive processes such as expectation. However, the interaction of brain activity cording sensory information and expectation in pain processing are not completely understood. Predictive coding models postulate specific hypothesis about the interplay between bottom-up sensory information and top-down expectations in terms of prediction errors and predictions, respectively. They further implicate brain oscillations at different frequencies, which play a crucial role in processing prediction errors and predictions. More specifically, recent evidence in visual and auditory modalities suggests that predictions are reflected by alpha (8-13 Hz) and beta oscillations (14-30 Hz) and prediction errors by gamma oscillations (60-100 Hz). However, for the processing of pain, these frequency-specific relationships have not been addressed so far. The current project aims to investigate brain activity which reflects predictions, prediction errors and sensory evidence in pain processing using a cueing paradigm. To this end, we will apply painful stimuli with low and high intensity to the dorsum of the left hand in 50 healthy subjects. A visual cue, preceding to each painful stimulus, will predict the intensity of the consecutive painful stimulus (low vs. high) with a probability of 75%. After each painful stimulus, participants will be asked to rate the perceived pain intensity. Electroencephalography (EEG) and skin conductance will be recorded continuously during anticipation and stimulation intervals. This paradigm enables us to compare pain-associated brain responses of validly and invalidly cued trials, i.e. the representation of the prediction error, on the one hand. On the other hand, brain activity related to predictions can be investigated in the anticipation interval preceding to the painful stimulus by comparing trials with low and high intensity cues. Further, we will compare models including predictions, prediction error and sensory evidence to ascertain the involvement of each brain response in processing sensory information and expectation. Results of the study promise to elucidate the interplay of predictions, predictions errors and sensory evidence in pain processing and how they differentially relate to neural oscillations at different frequency bands and pain-evoked responses.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Temporal-spectral signaling of sensory information and expectations in the cerebral processing of pain.
Nickel MM, Tiemann L, Hohn VD, May ES, et al · · 2022 · cited 39× · PMID 34983852 · DOI 10.1073/pnas.2116616119 -
Local brain oscillations and interregional connectivity differentially serve sensory and expectation effects on pain.
Bott FS, Nickel MM, Hohn VD, May ES, et al · · 2023 · cited 17× · PMID 37075123 · DOI 10.1126/sciadv.add7572
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04296968 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Technical University of Munich
- Last refreshed: 1 April 2021
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