CClinicalTrials.gg
Active, not recruitingNCT05293431MBNPRUpdated Jun 23, 2023

Promote Brain Resilience for the Coronavirus (COVID-19) Pandemic

An interventional study of Transcranial Alternate Current Stimulation and Sham stimulation in Transcranial Direct Current Stimulation, Mental Health Issue and Public Health, sponsored by Institut Guttmann. Active, not recruiting at 1 site in Spain. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Institut Guttmann · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 2 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

Background:

By the end of 2020, the coronavirus disease (COVID-19) pandemic resulted in over 84 million cases and nearly 2 million deaths.

Continued confinement and restriction are expected to negatively affect mental health, however, some individuals are likely to show much less negative impact than others. The characterization and neurobiological determinants of brain resilience vs vulnerability during the pandemic should generate critical knowledge and open future avenues for individually tailored interventions.

Objectives:

  1. Identify the individual psychobiological determinants of resilience during COVID-19 pandemic.
  2. Conduct a non-invasive brain stimulation intervention to modulate the expression of resilience brain networks.

Methods:

Barcelona Brain Health Initiative participants will be included, encompassing multiple assessments before and during the COVID-19 pandemic. Machine learning techniques will be applied to define brain networks signature of resilience. Subsequently transcranial alternating stimulation will be used during a controlled trial intervention to promote the expression of brain resilience networks.

Expected results:

The present project should provide critical new knowledge on brain mechanisms underlying resilience and first evidences of the feasibility and impact of modulating brain resilience networks in terms of its effects on mental health of participants.

Read the detailed description

As of the end of 2020, the coronavirus (COVID-19) pandemic had resulted in over 88 million confirmed cases and nearly 2 million deaths worldwide. Recurring waves of infection are forcing to impose continuing social restrictions and confinement measures all around the world.

From a public health perspective, these measures could potentially have an important negative impact on society and has led to the call for development of preventive and interventional strategies.

However despite the generalized negative effects of infection some individuals seem relatively protected from negative sequelae. Therefore, some people appear to be particularly resilient and the characterization and better understanding of characteristics that explain why some remain resilient has been highlighted as a critical focus of needed research, as it allows the potential to identify factors that can be targets for designing interventional strategies.

Resilience, the concept that describes the capacity of certain individuals to resist the impact of illness and distress, is a broad term. In clinical psychology and mental health, the concept of resilience has been historically been linked to the study of individual differences (e.g., self-esteem, sense of control, perception of social support, etc.) that determine the capacity to cope with the impact of life traumas in order to maintain normal psychological and physical functioning and avoid serious mental illness.

Beyond the psychological aspects, the determinants and factors that confer individual differences in resilience require integrated assessment of specific person's social context, engagement in positive lifestyles, and their interplay with its brain biological substrates and mechanisms. Neuroimaging investigations have identified brain regions that show specific activity and connectivity patterns during exposure to stressful or violent stimuli and that may be correlated with scores in psychosocial scales of resilience or predict subsequent coping abilities. Within the field of ageing and dementia some studies have suggested the role of the frontal cortex, specifically the functional connectivity of the dorsolateral prefrontal cortex to the rest of the brain or to particular networks (DMN, SN), as a neural substrate of higher resilience, both in normal aging.

A critical aspect to consider is that, while it is tempting to leverage such neuroimaging studies to try to identify a "human brain network of resilience", animal work on the neural substrate of resilience illustrates the importance of interventional experimental designs that employ stimuli that can be precisely quantified and controlled. Novel neuroscience approaches allow to undertake substantial translational work to enable the study of the neural substrates of resilience in humans, probing in a more direct causal association between brain circuit function and metrics of cognitive function or behavioral assessment - or subjective, i.e., related to wellbeing. As an example, the stress-response paradigm, offers a useful framework for the definition and study of resilience. It consists of three principal elements 1) a stressor; 2) an organism response; and 3) a given outcome.

Importantly, the experimental approach can also be applied to directly modulate the activity of brain networks subtending resilience processes.

Methods:

Can be actively modulate resilience? The main objective of subproject is to test the possibility to modulate the activity of the neural network underlying resilience and investigate the effects at the level of observable behavioral and neurophysiological changes.

Researchers propose a double-blind brain stimulation study.

Participants Participants will be pseudo-randomly selected, stratifying where possible for socio-demographical variables, amongst those individuals previously defined as "vulnerable".

Sample size was calculated considering the effect size of the few previous studies investigating the modulatory effect of non-invasive brain stimulation on functional and behavioral outcomes of resilience to stress previous studies of our group that showed how different non-invasive brain stimulation technique could differently modulate functional magnetic resonance (fMRI) derived brain networks dynamics or studies that employed stressor paradigms tasks to explore brain networks organization.

Non-invasive brain stimulation researchers will use transcranial alternating current stimulation (tACS), combined with neuroimaging data and high density EEG (hdEEG).

tACS utilizes low-amplitude alternating currents to modulate brain activity and entrain specific brain oscillations depending on the applied stimulation frequency. Researchers previously developed a method for optimizing the configuration of multifocal tACS for stimulation of specific brain networks (which effect can outlast the duration of stimulation and the use of a novel (sham) control stimulation paradigm will ensure the proper blinding of all participants.

tACS study protocol: general montage and configuration procedures tACS montages will be designed with the Stimweaver montage optimization algorithm to determine the positions and currents of the electrodes over the scalp that induce an electric field in the brain that better approximates a weighted target electric field map. Stimulation will be delivered using 8 circular electrodes with an area of 8 cm2. For safety issues, the maximum current delivered by any electrode will be 2 milliampere (mA), while the maximum current injected through all the electrodes will be 4 mA. In the real intervention conditions, the current will be supplied during the whole experimental session. In all groups, the current will be initially increased and finally decreased in a 30 s ramp-up and ramp-down fashion. For the sham condition, the current dosage will be composed of an initial ramp-up of 30 s immediately followed by a 1 min ramp- down, and a final ramp-down of 30 s immediately preceded by a ramp-up of 1 min. All stimulation parameters will adhere to general transcranial electrical stimulation current safety criteria guidelines.

Pre-post experimental stress coping paradigm To induce stress, researchers will use the moving-circles paradigm. In this task there are two circles moving sometimes closer and at times moving away from each other. When the circles touch, participants are delivered a mild electric stressor. Circle movement has a high degree of unpredictability and the circles might approach each other such that the stressor is more imminent, and then retreat from each other for a period.

Study design:

Double-blind controlled tACS study In order to evaluate the effect of stimulation on the modulation of the resilience networks, the researchers will implement a double-blind controlled trial using tACS.

Participants will receive tACS stimulation in two conditions which will be administered in a counterbalanced manner. In the first condition the researchers will target nodes of the resilience network identified by subproject#1, and in the second condition participants will receive sham stimulation. The study will be conducted in a double-blind manner.

02

Conditions studied

  • Transcranial Direct Current Stimulation
  • Mental Health Issue
  • Public Health
  • Resilience, Psychological
  • COVID-19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Institut Guttmann is the lead sponsor of 18 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No neurologic and neuropsychiatric diagnosis

Exclusion criteria

Exclusion Criteria:

  • Contraindication to receive safety tACS
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Active Stimulation Group

    This group will receive real tACS non-invasive brain stimulation

    Other: Transcranial Alternate Current Stimulation

  • Sham comparator
    Sham Control Group

    This group will receive Sham tACS non-invasive brain stimulation

    Other: Sham stimulation

Interventions

  • OtherTranscranial Alternate Current Stimulation

    tACS utilizes low-amplitude alternating currents to modulate brain activity and entrain specific brain oscillations depending on the applied stimulation frequency

  • OtherSham stimulation

    Sham stimulation will simulated the real tACS stimulation

06

What researchers measure

Primary outcomes

  1. Resilience scale

    Connor Davidson resilience scale (RISC-10)

    Time frame: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  2. Anxiety scale

    State and Trait Anxiety Inventory the efficacy of the stimulations (STAI)

    Time frame: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  3. Stress scale

    Holmes Stress Scale (HSS)

    Time frame: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  4. Stress scale

    Acute Stress Appraisal questionnaire (ASA)

    Time frame: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  5. Heart Rate

    During the stress inducing paradigm we will register heart rate variations

    Time frame: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  6. Pupillary response

    During the stress inducing paradigm we will register variations in the diameter of the pupil

    Time frame: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  7. Skin conductance response

    During the stress inducing paradigm we will register variations in the diameter of the pupil

    Time frame: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

  8. EEG signal

    We will explore changes in connectivity or oscillation of the network using EEG signal registered during the stress inducing task.

    Time frame: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

07

Study locations

1 site
  • Institut Guttmann
    Badalona, Barcelona 08916, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05293431
Lead sponsor
Institut Guttmann
Collaborators
University of Barcelona
Responsible party
Javier Solana Sanchez (PhD, Institut Guttmann) — Principal investigator
First posted
Mar 24, 2022
Start date
Sep 1, 2022
Primary completion
Jul 31, 2023 (estimated)
Completion
Nov 15, 2023 (estimated)
Last update
Jun 23, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion