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Positive and negative treatment expectations and their effects on placebo analgesia and nocebo hyperalgesia, as well as their temporal stability in patients with degenerative cerebellar diseases and healthy control participants

Positive and negative treatment expectations and their effects on placebo analgesia and nocebo hyperalgesia, as well as their temporal stability in patients with degenerative cerebellar diseases and healthy control participants - COLA-DCD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031702
Enrollment
56
Registered
2025-04-24
Start date
2023-07-06
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigation of pain perception in patients with degenerative cerebellar diseases and healthy, non-affected volunteers.

Interventions

Group 1: After assessing their heat pain thresholds and a comprehensive calibration of temperatures for mildly, moderately and severely painful heat stimuli, patients with degenerative cerebellar dise

Sponsors

Universitätsklinikum Essen (AöR), Klinik für Neurologie, Klinische Neurowissenschaften
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Consent of the participants 2. Minimum age: 18 years 3. Patients: degenerative cerebellar disease (e.g. SCA6 confirmed by molecular genetics)

Exclusion criteria

Exclusion criteria: Healthy participants: Presence of neurological (including seizure disorders) or psychiatric disorders Patients: Presence of neurological (including seizure disorder) or psychiatric disorders, excluding degenerative cerebellar diseases All participants: 1. Acute infections 2. Participation in similar learning trials in the past 3. Drug or alcohol abuse 4. Alcohol consumption on the previous day and/or on the test day 5. Drug use in the last 4 weeks 6. Consumption of centrally active medication with the exception of low-dose antidepressants 7. Intake of pain medication in the last 24 hours before the examination 8. Individuals with consumptive diseases and in poor general health 9. Acute skin damage (e.g. sunburn, injuries or major scarring) on the forearms (location of electrical and thermal stimulation). 10. Dermatological diseases 11. Contact allergies to the materials used in the test 12. Surgical interventions under anesthesia in the last 6 months 13. Individuals without legal capacity (adults) and those in official or judicial custody 14. Implanted pacemakers, neuro-stimulators, and drug pumps (due to electrical stimulation at the wrist) 15. Color blindness (e.g., red-green visual impairment)

Design outcomes

Primary

MeasureTime frame
Magnitude of placebo analgesia and nocebo hyperalgesia (difference in subjective pain intensity between the different experimental conditions (control vs. placebo = placebo analgesia; control vs. nocebo = nocebo hyperalgesia) on the day of conditioning in patients with degenerative cerebellar diseases and healthy participants as well as possible differences between the two experimental groups.

Secondary

MeasureTime frame
i) Extent of placebo analgesia and nocebo hyperalgesia one week after conditioning in patients with a degenerative cerebellar disease and healthy participants; ii) Heat pain thresholds in patients with a degenerative cerebellar disease and healthy participants; iii) Offset analgesia, i.e., the phenomenon that a stimulus (in this study a heat stimulus) is perceived as less painful when previously briefly stimulated with a higher intensity (here = temperature in degrees Celsius) in patients with a degenerative cerebellar disease and healthy participants; iv) Conditioned pain modulation (CPM), i.e. the phenomenon that a painful stimulus (conditioned stimulus) inhibits another painful stimulus (test stimulus) and thus influences the perceived pain intensity of the test stimulus in patient with a degenerative cerebellar disease and healthy subjects; v) Exploratory outcome measures are treatment tolerance and side effects on the 2 study days (GASE), psychometric predictors (prior experience with placebo treatment), somatosensory amplification (Somatosensory Amplification Scale, SSAS), perceived stress (Perceived Stress Scale, PSS), anxiety and depression as a state (State)/current state (State-Trait-Anxiety-Depression Inventory, STADI State), anxiety and depression as a trait (Trait)/ general state of anxiety and depression (STADI Trait), fear of pain (Fear of Pain Questionnaire - III (FPQ-III)), catastrophizing thoughts related to pain (Pain Catastrophizing Scale, PCS), personality factors (10-item Big Five Inventory), and a neuropsychological test to assess cerebellar cognitive impairment via the Cerebellar Cognitive Affective Syndrome (CCAS) scale.

Countries

Germany

Contacts

Public ContactFrederik Schlitt-Nguy?n

Universitätsklinikum Essen (AöR), Klinik für Neurologie, Experimentelle Neurologie

frederik.schlitt-nguyen@uk-essen.de00492017233815

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026