Home-based Stimulation to Promote Resilience

NCT06051071 | Unknown

• 1 other identifier: 201129-30-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Non-invasive brain stimulation showed to be effective in reduce stress related cognitive and mental-health consequences. Thanks to technological advances these devices are now very easy to use and suitable to hoe-based self-administration. Objective: Conduct a home-based and tele-supervised non-invasive brain stimulation intervention to modulate the expression of resilience brain networks. Methods: Transcranial direct current stimulation will be used duringa tele-supervised home-based stimulation intervention to promote the expression of brain resilience networks. Expected results: The present project should provide critical new knowledge and evidences of the feasibility and impact of modulating brain resilience networks in terms of its effects on mental health of participants, including the possibility to implement future self-administered, home-based interventions.

Conditions

Stress

Outcome Measures

Primary Outcomes (4)

• Changes in the Connor Davidson resilience scale

  A resilience scale scoring from 0 to 40, where higher score represent better resilience

  immediately after the intervention

• Changes in the State-Trait Anxiety Inventory

  Anxiety scale scoring from 0 to 80 where higher scores indicates greater anxiety

  immediately after the intervention

• Changes in the Holmes stress inventory

  stress scale scoring from 0 to 430 points, where higher scores indicates greater stress

  immediately after the intervention

• Adherence

  number of sessions completed

  immediately after the intervention

Secondary Outcomes (4)

• Heart rate variability changes

  immediately after the intervention

• Pupill dilatation changes

  immediately after the intervention

• Skin electrical activity changes

  immediately after the intervention

• EEG signal changes

  immediately after the intervention

Study Arms (1)

Treatment

EXPERIMENTAL

tDCS stimulation arm

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

In tDCS, surface electrodes (anode and cathode) inject low-intensity direct current through the skull to modulate brain activity and cortical excitability

Treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No psychiatric conditions or neurological disorders
• Do not present any contraindication for their safety in relation to the TDCS protocol (crew metal implants, pacemakers, medical infusion bomb, epilepsy history, brain surgeries, etc.)

You may not qualify if:

• alcohol or drug abuse
• pregnancy

Sponsors & Collaborators

• Institut Guttmann: lead
• University of Barcelona: collaborator

Study Sites (1)

Guttmann Barcelona

Barcelona, 08027, Spain

RECRUITING

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

Central Study Contacts

Javier Solana-Sanchéz, PhD

CONTACT

+34 934 977 700; jsolana@guttmann.com

Gabriele Cattaneo, PhD

CONTACT

T. +34 934 977 700; gcattaneo@guttmann.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: September 22, 2023
• Study Start: September 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (1)