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NCT Number: NCT04246853

Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

Non invasive brain stimulation (NIBS) of the primary motor cortex (M1) through transcranial direct current stimulation (tDCS) has been widely investigated in research and clinical settings in order to modulate brain plasticity and improve clinical pain. Interestingly, newly developed paradigms i.e. tDCS of the resting state motor network have proved higher modulatory effects in terms of corticospinal excitability when compared to traditional M1 tDCS.

However, little is known about the effects of tDCS on the frequency changes of alpha oscillations (alpha peaks).

Interestingly, previous studies show a correlation between reduced frequencies of alpha peaks during 1-hour experimental pain in comparison to baseline.

The present study aims to investigate the effects of tDCS of the resting state motor network on the frequency and power of alpha peaks during prolonged experimental pain during 24 hours.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Prolonged Experimental Pain Signs and Symptoms

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, Nordylland, 9000, Denmark

About this study

There is evidence that chronic pain alters the frequency of alpha peaks. Specifically, recent studies showed a correlation between decreased frequency of alpha peaks and perceived pain. Furthermore, a correlation was found between high pain sensitivity and slower alpha oscillations during prolonged pain during 1 hour.

To date, the effects of prolonged experimental pain during 24 hours on brain oscillations has not been explored. Moreover, it is unknown whether non invasive brain stimulation (NIBS) through transcranial direct current stimulation (tDCS) can revert these pain-related feature.

It is hypothesized that prolonged pain during 24 hours will reduce the frequency of alpha peaks and tDCS of the resting state motor network will revert it to baseline values.

Furthermore, it is thought that decreased frequency of alpha peaks will be correlated with perceived pain intensity on Day 1 (before receiving the first tDCS session).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Right-handed healthy men and women in the age 21-50 years who speak and understand English

Exclusion criteria

  • Lack of ability to cooperate
  • History of chronic pain or current acute pain
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Present and previous neurologic, musculoskeletal or mental illnesses
  • Chili allergies
  • Current use of medications that may affect the trial
  • Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
  • Failure to pass the questionnaire for tDCS

Treatment and study plan

Transcranial direct current stimulation (tDCS) of the resting state motor network

Device

Transcranial direct current stimulation (tDCS) delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.

Primary outcomes

  1. Frequency of alpha peaks

    Time frame: 24 hours

    The frequency of alpha peaks will be extracted through electroencephalography (EEG) in the sensorimotor areas (Central-Parietal) of the brain. It is hypothesized that the frequency of alpha peaks will be reduced due to prolonged pain. It is expected that tDCS of the resting state motor network will revert the frequency to baseline values or even higher.

  2. Perceived pain intensity

    Time frame: 24 hours

    Perceived pain intensity will be rated in a 0-10 Numerical rating scale (NRS): 0 no pain and 10 worst pain imaginable. Prolonged pain will increase perceived pain intensity. It is expected that active tDCS will not be able to reduce perceived pain intensity in comparison to sham tDCS.

Secondary outcomes

  1. Amplitude of alpha peak

    Time frame: 24 hours

    Similar to the primary outcome, the amplitude of the alpha peak will be extracted through EEG in the sensorimotor area. It is expected that prolonged pain will be able to reduce the amplitude of alpha peaks and tDCS will increase it back to baseline values or even higher.

  2. Power of alpha oscillations

    Time frame: 24 hours

    Spectral analysis will be performed on alpha activity and it is expected that this outcome will be reduced by prolonged pain and tDCS of the resting state motor network will be able to normalize it.

Other outcomes

  1. Amplitude of Mu-oscillations during motor imagery

    Time frame: 24 hours

    Amplitude of Mu-oscillations will be extracted from EEG during motor imagery tasks (abduction-adduction of index finger). It is expected that prolonged pain and motor imagery will produce a desynchronization of Mu-oscillations and on the contrary active tDCS will be able to synchronize it back similar to pain-free state.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Effects of Non Invasive Brain Stimulation on Experimental Pain

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2020
Registry last updated
Nov 20, 2020

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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