Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

NCT04551118 | Completed DMC

• 1 other identifier: tES-2019-TJAH
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

transcranial Electrical Stimulation (tES)

Outcome Measures

Primary Outcomes (2)

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

  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.

  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 Outcomes (4)

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

  Day1, Day7

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

  Day1, Day7

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

  Day1, Day7

• Adverse events from baseline to Day1.

  Day2, Day3, Day4, Day5, Day6, Day7

Study Arms (3)

tACS group

EXPERIMENTAL

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

tDCS group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

Participants receive sham stimulation that administered similarly, but with current continued less than 30s.

Device: Transcranial electrical stimulation (TES)-sham

Interventions

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.

Also known as: tACS active

tACS group

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.

Also known as: tDCS active

tDCS group

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.

Sham group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: July 1, 2019
• Primary Completion: August 20, 2020
• Study Completion: September 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

CN (1)