Clinical trial NCT05570695: How do Alpha Oscillations Shape the Perception of Pain? - An EEG-based Neurofeedback Study
Official title: How do Alpha Oscillations Shape the Perception of Pain? - An EEG-based Neurofeedback Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental Pain in Healthy Human Subjects
Keywords: pain
neurofeedback
alpha
neural oscillations
attention
brain
registered report
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Studienstiftung des deutschen Volkes
First posted: 2022-10-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will participate in 4 experimental conditions differing with respect to the administered neurofeedback training: (1) attention right training, ARTNF; (2) attention left training, ALTNF; (3) sham attention right training, ARTsham; (4) sham attention left training, ALTsham. During neurofeedback, noxious stimuli will be applied to the dorsum of the left hand using cutaneous laser stimulation (Nd:YAP laser, Stimul 1340, DEKA M.E.L.A. srl, Calenzano, Italy; stimulation settings: 4 ms duration, 7 mm stimulus diameter, 3.5 J laser intensity) while pain ratings will be recorded.
Primary purpose: BASIC_SCIENCE

Brief summary: Pain is closely linked to alpha oscillations (8 -13 Hz) which are thought to represent a supra-modal, top-down mediated gating mechanism that shapes sensory processing. Consequently, alpha oscillations might also shape the cerebral processing of nociceptive input and eventually the perception of pain. To test this mechanistic hypothesis, the investigators designed a sham-controlled and double-blind electroencephalography (EEG)-based neurofeedback study. In a short-term neurofeedback training protocol, healthy participants will learn to up- and downregulate somatosensory alpha oscillations using attention. Subsequently, the investigators will investigate how this manipulation impacts experimental pain applied during neurofeedback. Using Bayesian statistics and mediation analysis, the investigators will test whether alpha oscillations mediate attention effects on pain perception. This approach promises causal insights into the role of alpha oscillations in shaping pain, and thereby extends previous correlative evidence. Beyond, it can aid the development of novel, non-invasive modulatory treatment approaches for chronic pain, which are urgently needed.

The prosed study protocol has been granted in-principle acceptance from PLOS Biology and the corresponding registration can be found at the OSF online repository \[www.osf.io/qbkj2\].


Eligibility criteria: Inclusion Criteria:

* aged 18-45 years
* right-handedness (laterality quotient \> 60 on the Edinburgh handedness inventory)
* good command of German
* written informed consent
* attendance at both sessions and compliance with instructions throughout the experiment

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 medication (aside from contraception, thyroidal, and antiallergic medication)
* surgical procedures involving the head or spinal cord
* side-effects following previous thermal stimulation
* contact to a person with a SARS-CoV-2 infection within the last 2 weeks
* current symptoms of a cold or flu

Primary outcomes:
measure: Alpha asymmetry index (AAI) during neurofeedback
timeFrame: During procedure (neurofeedback)
measure: Pain ratings during neurofeedback (NRS; 1: 'no pain' to 100: 'worst tolerable pain')
timeFrame: During procedure (neurofeedback)
measure: Pain-related brain responses during neurofeedback
timeFrame: During procedure (neurofeedback)
Secondary outcomes:
measure: Motivation to participate in the training measured by a numerical rating scale (NRS; 1: 'very low' to 7: 'very high')
timeFrame: Before each session
measure: General self-efficacy (German version of the General Self-Efficacy Scale, GSE, minimum score: 10, maximum score: 40)
timeFrame: Before each session
measure: Health-related locus of control (Multidimensional Health Locus of Control Scales, MHLC, minimum score: 3, maximum score: 15)
timeFrame: Before each session
measure: Current positive or negative affect (Positive and Negative Affect Schedule, PNAS, minimum score: 10, maximum score: 50)
timeFrame: Before each session
measure: Perceived task demand (NRS; 1: 'very low' to 7: 'very high')
timeFrame: After each condition
measure: Effort exerted (NRS; 1: 'very low' to 7: 'very high')
timeFrame: After each condition
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Neurology, Klinikum rechts der Isar, Technical University of Munich
state: Bavaria
Study officials:
affiliation: Department of Neurology, Klinikum rechts der Isar, Technical University of Munich
name: Markus Ploner, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
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