Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

September 10, 2020 updated by: Tianjin Anding Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300222
        • Tianjin Anding Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day1, Day7
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.
Day1, Day7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day1, Day7
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.
Day1, Day7
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.
Day1, Day7
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.
Day2, Day3, Day4, Day5, Day6, Day7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Anding Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

August 20, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • tES-2019-TJAH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Transcranial alternating current stimulation (tACS) -active

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe