NCT05293431

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

March 16, 2022

Last Update Submit

June 21, 2023

Conditions

Transcranial Direct Current StimulationMental Health IssuePublic HealthResilience, PsychologicalCOVID-19

Outcome Measures

Primary Outcomes (8)

  • Resilience scale

    Connor Davidson resilience scale (RISC-10)

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

  • Anxiety scale

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

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

  • Stress scale

    Holmes Stress Scale (HSS)

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

  • Stress scale

    Acute Stress Appraisal questionnaire (ASA)

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

  • Heart Rate

    During the stress inducing paradigm we will register heart rate variations

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

  • Pupillary response

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

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

  • Skin conductance response

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

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

  • EEG signal

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

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

Study Arms (2)

Active Stimulation Group

EXPERIMENTAL

This group will receive real tACS non-invasive brain stimulation

Other: Transcranial Alternate Current Stimulation

Sham Control Group

SHAM COMPARATOR

This group will receive Sham tACS non-invasive brain stimulation

Other: Sham stimulation

Interventions

Transcranial Alternate Current StimulationOTHER

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

Active Stimulation Group
Sham stimulationOTHER

Sham stimulation will simulated the real tACS stimulation

Sham Control Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No neurologic and neuropsychiatric diagnosis

You may not qualify if:

  • Contraindication to receive safety tACS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 24, 2022

Study Start

September 1, 2022

Primary Completion

July 31, 2023

Study Completion

November 15, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

ES(1)