Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Transcranial electrical stimulation (TES)-sham; Device: Transcranial alternating current stimulation (tACS) -active; Device: Transcranial direct current stimulation (tDCS)-active

• Registration Number: NCT04551118
• Lead Sponsor: Tianjin Anding Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-08-20
• Status Verified: 2020-09
• Study Completion: 2020-09-01
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Transcranial electrical stimulation (TES)-sham	Participants receive sham stimulation that administered similarly, but with current continued less than 30s.
tACS group	Transcranial alternating current stimulation (tACS) -active	Participants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.
tDCS group	Transcranial direct current stimulation (tDCS)-active	Participants receive 20 min sessions of 1.5 mA direct current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.

Primary Outcome Measures

Name	Time	Method
The change of event-related potentials (ERPs) before and after stimulation.	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.
The change of resting EEG power and lateralization index before and after stimulation.	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 Outcome Measures

Name	Time	Method
The change of scores in subjective scale measurement of Difficulties in Emotion Regulation Scale (DERS) from pre- to post-stimulation.	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.
Adverse events from baseline to Day1.	Day2, Day3, Day4, Day5, Day6, Day7	The aim is to evaluate the adverse effects during the stimulation.
The change of scores in subjective scale measurement of State-Trait Anxiety Inventory from pre- to post-stimulation.	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.
The change of behavioral data from pre- to post-stimulation.	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.

Trial Locations

Locations (1)

Tianjin Anding Hospital; 🇨🇳 Tianjin, Tianjin, China