Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

NCT ID: NCT04551118

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-09-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

tACS group

Participants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.

Group Type: EXPERIMENTAL

Transcranial alternating current stimulation (tACS) -active

Intervention Type: 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.

tDCS group

Participants receive 20 min sessions of 1.5 mA direct current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)-active

Intervention Type: 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.

Sham group

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

Group Type: SHAM_COMPARATOR

Transcranial electrical stimulation (TES)-sham

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

tACS active; tDCS active

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Anding Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

tES-2019-TJAH

Identifier Type: -

Identifier Source: org_study_id