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Completed

NCT Number: NCT05570695

How do Alpha Oscillations Shape the Perception of Pain? - An EEG-based Neurofeedback Study

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].

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Key information

Conditions

Experimental Pain in Healthy Human Subjects Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

attention right training, ARTNF

Behavioral

In a first verum neurofeedback condition, participants will be instructed to focus attention on their right hand and the up-regulation of alpha oscillations in the right hemisphere relative to alpha oscillations in the left hemisphere will be incentivized through neurofeedback.

attention left training, ALTNF

Behavioral

In a second verum neurofeedback condition, participants will be instructed to focus attention on their left hand and the down-regulation of right relative to left alpha oscillations will be incentivized.

sham attention right training, ARTsham

Behavioral

During the first sham neurofeedback condition, participants will be instructed to focus attention on their right hand. However, the feedback signal will not mirror their brain activity. Instead, the feedback signal and the corresponding reward of the last matching verum condition completed by a previous participant, i.e., ARTNF for ARTsham, will be replayed (yoked feedback).

sham attention left training, ALTsham

Behavioral

During the second sham neurofeedback condition, participants will be instructed to focus attention on their left hand. However, the feedback signal will not mirror their brain activity. Instead, the feedback signal and the corresponding reward of the last matching verum condition completed by a previous participant, i.e., ALTNF for ALTsham, will be replayed (yoked feedback).

Primary outcomes

  1. Alpha asymmetry index (AAI) during neurofeedback

    Time frame: During procedure (neurofeedback)

    During neurofeedback, brain activity will be recorded continuously and the AAI will be extracted. Subsequently, AAIs will be compared between neurofeedback conditions. Details regarding the complete analysis pipeline can be found at the OSF online repository [www.osf.io/qbkj2].

  2. Pain ratings during neurofeedback (NRS; 1: 'no pain' to 100: 'worst tolerable pain')

    Time frame: During procedure (neurofeedback)

    At the end of each neurofeedback trial, participants will verbally rate the perceived intensity of a cutaneous laser stimulus. Subsequently, pain ratings will be compared between neurofeedback conditions. Details regarding the complete analysis pipeline can be found at the OSF online repository [www.osf.io/qbkj2].

  3. Pain-related brain responses during neurofeedback

    Time frame: During procedure (neurofeedback)

    During neurofeedback, brain activity will be recorded continuously, and the pain-related brain responses will be extracted. Subsequently, pain-related brain responses will be compared between neurofeedback conditions. Details regarding the complete analysis pipeline can be found at the OSF online repository [www.osf.io/qbkj2].

Secondary outcomes

  1. Motivation to participate in the training measured by a numerical rating scale (NRS; 1: 'very low' to 7: 'very high')

    Time frame: Before each session

    The motivation to participate in the training will be assessed using a self-report measure.

  2. General self-efficacy (German version of the General Self-Efficacy Scale, GSE, minimum score: 10, maximum score: 40)

    Time frame: Before each session

    General self-efficacy will be assessed using the German version of the General Self-efficacy Scale.

  3. Health-related locus of control (Multidimensional Health Locus of Control Scales, MHLC, minimum score: 3, maximum score: 15)

    Time frame: Before each session

    The health-related locus of control will be assessed using Multidimensional Health Locus of Control Scales.

  4. Current positive or negative affect (Positive and Negative Affect Schedule, PNAS, minimum score: 10, maximum score: 50)

    Time frame: Before each session

    The current positive or negative affect will be assessed using the Positive and Negative Affect Schedule.

  5. Perceived task demand (NRS; 1: 'very low' to 7: 'very high')

    Time frame: After each condition

    The perceived task demand will be assessed using a self-report measure.

  6. Effort exerted (NRS; 1: 'very low' to 7: 'very high')

    Time frame: After each condition

    The effort exerted will be assessed using a self-report measure.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • German Research Foundation
  • Studienstiftung des deutschen Volkes

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2022
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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