HealthyNCT04551118

Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

A study testing Transcranial alternating current stimulation (tACS) -active and Transcranial direct current stimulation (tDCS)-active in people with Healthy, run by Tianjin Anding Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Transcranial alternating current stimulation (tACS) -active and Transcranial direct current stimulation (tDCS)-active
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 1 siteChina
Study dates: 1 Jul 2019to 1 Sep 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300222

Other trials in China

About this study

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

Read the 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
Being tested: Transcranial alternating current stimulation (tACS) -active, Transcranial direct current stimulation (tDCS)-active, Transcranial electrical stimulation (TES)-sham
Keywords: transcranial Electrical Stimulation (tES)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial alternating current stimulation (tACS) -activeDevice
Also called 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.
Transcranial direct current stimulation (tDCS)-activeDevice
Also called 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.
Transcranial electrical stimulation (TES)-shamDevice
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.

Study groups in NCT04551118
Study group	Role	What they receive
tACS group	Experimental	Participants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days. Receives: 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. Receives: 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. Receives: Device: Transcranial electrical stimulation (TES)-sham

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day1, Day7

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20191 Sep 2020

First posted16 Sep 2020
Study start1 Jul 2019
Primary completion20 Aug 2020
Study completion1 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04551118
Sponsor's protocol ID: tES-2019-TJAH
Status last verified: Sep 2020
First submitted: 8 Sep 2020
Last updated: 16 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Transcranial Electrical Stimulation (tES) of Dorsolateral- Prefrontal Cortex on Emotion Processing: A Randomized, Single-blind, Sham-controlled Trial
ClinicalTrials.gov ID: NCT04551118
Acronym / sponsor ID: tES-2019-TJAH
Conditions: Healthy
Keywords: transcranial Electrical Stimulation (tES)
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Tianjin Anding HospitalUniversity, hospital or other
Study start: 1 Jul 2019 (actual)
Primary completion: 20 Aug 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 16 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
tACS group	Experimental	Device: Transcranial alternating current stimulation (tACS) -activeParticipants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.
tDCS group	Experimental	Device: Transcranial direct current stimulation (tDCS)-activeParticipants receive 20 min sessions of 1.5 mA direct current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.
Sham group	Sham comparator	Device: Transcranial electrical stimulation (TES)-shamParticipants receive sham stimulation that administered similarly, but with current continued less than 30s.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial alternating current stimulation (tACS) -activeAlso: tACS activeTranscranial 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.	Device	tACS group
Transcranial direct current stimulation (tDCS)-activeAlso: tDCS activeTranscranial 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.	Device	tDCS group
Transcranial electrical stimulation (TES)-shamTranscranial 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.	Device	Sham group

Primary outcome

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.

4 secondary outcomes

The change of scores in subjective scale measurement of State-Trait Anxiety Inventory from pre- to post-stimulation.
Time frame: 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 change of behavioral data from pre- to post-stimulation.
Time frame: Day1, Day7
Adverse events from baseline to Day1.
Time frame: Day2, Day3, Day4, Day5, Day6, Day7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.

Related trials for Healthy

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of event-related potentials (ERPs) before and after stimulation. (time frame: Day1, Day7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.