Home-based Non-invasive Brain Stimulation for Treatment-resistant Depression Feasibility, Efficacy and Biomarker of Treatment Response

NCT05930509 | Active Not Recruiting

• 1 other identifier: Institut Guttmann
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Depression has a yearly prevalence superior to 5%, but a 30% of patients cannot benefit of pharmacological treatment, resulting resistant to it. Transcranial direct current stimulation, due to its reduced invasiveness and easy administration showed to be a useful technique to treat these cases, and it is now broadly used in clinical practice. Moreover, thanks to technological advances, this treatment could be self-administered at home, reducing costs and improving scalability. The aim of this study is to confirm the efficacy, safety and feasibility of a home-based intervention for treatment-resistant depression To do this participants will perform a home-based tDCS intervention consisting of 30 minutes sessions, 5 days per week, for 4 weeks. Results should provide critical knowledge regarding home-based therapies for the treatment of resistant depression and evidence on brain mechanisms underlying response to non-invasive brain stimulation.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Adherence

  Number of session completed

  immediately after the intervention

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidences related with the stimulation

  immediately after the intervention

Secondary Outcomes (6)

• Changes in the Montgomery-Åsberg Depression Rating Scale

  baseline and immediately after the intervention

• Changes in the Beck Depression Inventory

  baseline and immediately after the intervention

• Changes in the Hamilton Depression Rating Scale

  baseline and immediately after the intervention

• Changes in the Quick Inventory of Depressive Symptomatology

  baseline and immediately after the intervention

• Changes in the Montreal Cognitive Assessment

  baseline and immediately after the intervention

Study Arms (1)

Treatment

EXPERIMENTAL

tDCS stimulation

Device: Non-invasive transcranial direct current stimulation (tDCS)

Interventions

Non-invasive transcranial direct current stimulation (tDCS) DEVICE

Electrical stimulation

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet criteria and be diagnosed by a Psychiatrist for MDD, according to the Diagnostic and Statistical Manual of Mental Disorders
• Score at least 20 on the Montgomery-Åsberg Depression Rating Scale
• Be stable enough to participate in the study without risk for safety.
• Live with an adult with computer skills and willingness to learn how to use tDCS.

You may not qualify if:

• Present other psychiatric conditions or neurological disorders
• Abuse of alcohol or drugs
• Pregnancy
• Present any contraindication for tDCS

Sponsors & Collaborators

• Institut Guttmann: lead
• University of Barcelona: collaborator

Study Sites (1)

Guttmann Barcelona

Barcelona, Barcelona, 08027, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will receive the same treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open clinical trial

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 5, 2023
• Study Start: June 15, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

ES (1)