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Completed

NCT Number: NCT03805854

Modulating Pain Using Transcranial Alternating Stimulation (tACS) in Healthy Human Subjects

Pain is a highly complex and subjective phenomenon which results from the dynamic integration of sensory and contextual (i.e. cognitive, emotional, and motivational) processes. Recent evidence suggests that neural oscillations and their synchronization between different brain areas might form the basis of these integrative functions. When investigating tonic experimental pain lasting for several minutes, for example, objective stimulus intensity is inversely related to alpha (8-13 Hz) and beta (13-30 Hz) oscillations in early somatosensory areas, while subjective pain intensity is positively associated with gamma (30-100 Hz) oscillations in prefrontal cortex. Yet, with a few exemptions, reported links between oscillatory brain activity and pain have mostly been established by correlative approaches which do not allow to infer causality. The current project aims at comprehensively investigating the causal role of neural oscillations for tonic experimental pain in healthy human subjects. To this end, transcranial alternating current stimulation (tACS) will be employed to modulate oscillatory brain activity in alpha and gamma frequency bands and investigate effects of this manipulation on pain perception and pain-related autonomic responses. Using an established tonic pain stimulation protocol and a double-blind, sham-controlled design, effects of tACS of somatosensory as well as prefrontal brain areas will be investigated. Results promise to elucidate the neural mechanisms underlying tonic experimental pain by testing the mechanistic role of neural oscillations in different aspects of pain processing. Furthermore, they might contribute to the development of urgently needed new treatment approaches for chronic pain using neuromodulatory methods.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

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 18-65 years
  • Right-handedness
  • Written informed consent

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
  • Surgical procedures involving the head or spinal cord
  • Head trauma followed by impairment of consciousness
  • Past fainting spells or syncopes
  • Metal (except titanium) or electronic implants
  • Side-effects following previous electrical or magnetic stimulation
  • Side-effects following previous thermal stimulation

Treatment and study plan

10 Hz tACS of the bilateral somatosensory cortex

Device

10 Hz tACS at 1 mA will be applied over the bilateral somatosensory cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions CP3 and CP4 according to the international 10-20 system.

10 Hz tACS of the prefrontal cortex

Device

10 Hz tACS at 1 mA will be applied over the prefrontal cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions F3 and F4 according to the international 10-20 system.

80 Hz tACS of the bilateral somatosensory cortex

Device

80 Hz tACS at 1 mA will be applied over the bilateral somatosensory cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions CP3 and CP4 according to the international 10-20 system.

80 Hz tACS of the prefrontal cortex

Device

80 Hz tACS at 1 mA will be applied over the prefrontal cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions F3 and F4 according to the international 10-20 system.

Sham stimulation of the bilateral somatosensory cortex

Device

10 Hz tACS at 1 mA will be applied over the bilateral somatosensory cortex for 10 seconds at the beginning of the experimental session using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions CP3 and CP4 according to the international 10-20 system.

Sham stimulation of the prefrontal cortex

Device

10 Hz tACS at 1 mA will be applied over the prefrontal cortex for 10 seconds at the beginning of the experimental session using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber placed at electrode positions F3 and F4 according to the international 10-20 system.

Primary outcomes

  1. Changes in pain rating on visual analogue scale (VAS; 0: 'no pain' to 10: 'maximal tolerable pain') between sessions

    Time frame: During 10 min thermal stimulation in each of six interventions (10 Hz tACS/80 Hz tACS/sham stimulation of the somatosensory/prefrontal cortex), which are separated by at least 24 hrs.

    During thermal stimulation, participants will be instructed to continuously rate the currently perceived pain intensity using a finger-span device.

  2. Changes in skin conductance responses (µS) between sessions

    Time frame: During 10 min thermal stimulation in each of six interventions (10 Hz tACS/80 Hz tACS/sham stimulation of the somatosensory/prefrontal cortex), which are separated by at least 24 hrs.

    Skin conductance responses will be recorded using two electrodes attached to the index and middle finger of the left hand.

  3. Changes in heart rate (BPM, beats per minute) between sessions

    Time frame: During 10 min thermal stimulation in each of six interventions (10 Hz tACS/80 Hz tACS/sham stimulation of the somatosensory/prefrontal cortex), which are separated by at least 24 hrs.

    The electrocardiogram (ECG) will be recorded using two electrodes placed under the right clavicle and below the sternum, respectively.

  4. Changes in oscillatory brain activity before and after tACS application within each session

    Time frame: Measured immediately before and after the tACS protocol in each of six interventions (10 Hz tACS/80 Hz tACS/sham stimulation of the somatosensory/prefrontal cortex), which are separated by at least 24 hrs.

    5-minute resting state electroencephalogram (EEG) will be recorded with two electrodes placed at the same electrode positions used for the respective tACS protocol. Power of oscillatory brain activity will be quantified in the alpha (8-12 Hz) and gamma (30-100 Hz) bands.

Secondary outcomes

  1. Perception of tACS induced visual and skin sensations measured by numerical rating scale (NRS; 0: 'no sensation' to 10: 'very strong sensation')

    Time frame: Measured immediately after the EEG measurement following each of six interventions (10 Hz tACS/80 Hz tACS/sham stimulation of the somatosensory/prefrontal cortex), which are separated by at least 24 hrs.

    The perception of visual and skin sensations induced by the tACS protocols will be assessed using a custom questionnaire.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • German Research Foundation

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Jun 4, 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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