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Completed

NCT Number: NCT04551118

Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

The aim of this study is to assess the efficacy of transcranial Electrical Stimulation (tES) on emotion processing of healthy participants. Meanwhile, the investigators evaluate the effect of tES on electroencephalography (EEG) of both resting and task-related signal. The hypothesis of this study is that tES can improve the cognitive function of emotion by modulating brain activity.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

About this study

This is a randomized, single-blind, sham-controlled study using transcranial Electrical Stimulation (tES) for 7-day treatment. Participants were randomly assigned to transcranial alternating current stimulation (tACS) group, transcranial direct current stimulation (tDCS) group or sham-control group. Active tES comprised 20 min sessions of 1.5 mA peak-to-peak current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days. Sham group was administered similarly, but with current turned off after 30s. Apart from studying the effects of tES on physiology signals, subjective scale assessments and behavioral data are performed before and after the treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age between 18 and 35 years
  • with normal or corrected to normal vision
  • participant or guardian need to sign informed consent

Exclusion criteria

  • reported neurological or psychiatric disorders
  • history of any form of transcranial electrical stimulation experience
  • use of mood stabilizer
  • history of substance abuse or dependence
  • severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma
  • use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
  • use of immunosuppressive medication such as oral steroid hormones women in pregnancy or lactation period

Treatment and study plan

Transcranial alternating current stimulation (tACS) -active

Device

Transcranial alternating current stimulation (tACS) is a non-invasive neuromodulation technique of the brain with an AC micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.

Other names: tACS active

Transcranial direct current stimulation (tDCS)-active

Device

Transcranial direct current stimulation (tDCS) is a non- invasive neuromodulation technique of the brain with a DC micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive 20 min sessions of 1.5 mA direct current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.

Other names: tDCS active

Transcranial electrical stimulation (TES)-sham

Device

Transcranial electrical stimulation (TES) is a non-invasive neuromodulation technique of the brain with micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive sham stimulation over the dorsolateral prefrontal cortex, with current turned off after 30 second. The session last 20 min for 7 consecutive days.

Primary outcomes

  1. The change of event-related potentials (ERPs) before and after stimulation.

    Time frame: Day1, Day7

    The aim is to explore whether tES have a regulation effect on emotion processing of dynamic course. In the task, participants need to concentrate on the emotional picture with positive, negative and neutral faces. Then, different ERP components elicited by positive, negative and neutral faces using the signals recorded during facial emotion identification task. The investigators will analyze the ERP components change before and after stimulation to access tES effect on emotion processing.

  2. The change of resting EEG power and lateralization index before and after stimulation.

    Time frame: Day1, Day7

    The aim is to explore whether tES have a regulation effect at-risk of frequency domain. In the resting task, 8 mins resting EEG will be recorded. During recording, participants need to remain still and relaxed with their eyes open (O) and closed (C) in two alternating orders. In order to access tES effect on resting EEG, spectral analysis will be executed after the experiment. Analysis in frequency domain also contributed to expound the brain mechanism related cerebral cortex in emotion processing. In specific, EEG power of delta, theta, alpha, beta and gamma band would be calculated after recording. Besides, the EEG lateralization index also be analyzed between left and right brain.

Secondary outcomes

  1. The change of scores in subjective scale measurement of State-Trait Anxiety Inventory from pre- to post-stimulation.

    Time frame: Day1, Day7

    The main objective is to explore whether tES has an effect on subjective scale after stimulation. The scales include State-Trait Anxiety Inventory (STAI) and Difficulties in Emotion Regulation Scale (DERS). The STAI is a brief self-report assessment for trait anxiety and state measurement. The scales contain two 20-item pools of emotional state and personality trait, each item rated on a 4-point intensity scale ranging from not at all to very much so or from never to almost always respectively. DERS, on the other hand, is also a self-report measure function to assess the emotion regulation.

  2. The change of scores in subjective scale measurement of Difficulties in Emotion Regulation Scale (DERS) from pre- to post-stimulation.

    Time frame: Day1, Day7

    The main objective is to explore whether tES has an effect on subjective scale after stimulation. Difficulties in Emotion Regulation Scale (DERS), which is also a self-report measure function to assess the emotion regulation.

  3. The change of behavioral data from pre- to post-stimulation.

    Time frame: Day1, Day7

    The aim is to explore whether tES have a regulation effect on emotion identification task. During the task, participants need to respond as quickly as probable to emotional stimuli by pressing the space bar. Reaction time and accuracy from the facial emotion identification task pre- and post-stimulation would be recorded. After the experiment, the investigators will access the stimulation effect on their behavioral data change.

  4. Adverse events from baseline to Day1.

    Time frame: Day2, Day3, Day4, Day5, Day6, Day7

    The aim is to evaluate the adverse effects during the stimulation.

Sponsors and collaborators

Lead sponsor

Tianjin Anding Hospital

Other

Registry information

Official study title

Efficacy of Transcranial Electrical Stimulation (tES) of Dorsolateral- Prefrontal Cortex on Emotion Processing: A Randomized, Single-blind, Sham-controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Sep 16, 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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