Skip to main content
Clinical Trials/NCT04551118
NCT04551118
Completed
Not Applicable

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

Tianjin Anding Hospital1 site in 1 country102 target enrollmentJuly 1, 2019
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Tianjin Anding Hospital
Enrollment
102
Locations
1
Primary Endpoint
The change of event-related potentials (ERPs) before and after stimulation.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
September 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

  • The change of scores in subjective scale measurement of Difficulties in Emotion Regulation Scale (DERS) from pre- to post-stimulation.(Day1, Day7)
  • Adverse events from baseline to Day1.(Day2, Day3, Day4, Day5, Day6, Day7)
  • The change of scores in subjective scale measurement of State-Trait Anxiety Inventory from pre- to post-stimulation.(Day1, Day7)
  • The change of behavioral data from pre- to post-stimulation.(Day1, Day7)

Study Sites (1)

Loading locations...

Similar Trials