Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: Neurofeedback sessions

• Registration Number: NCT06098469
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-24
• Status Verified: 2024-03
• Study Start: 2024-10-10
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Subjects aged 25 to 65 included
• Information and signed informed consent
• Patients with a diagnosis of major depressive episode in remission
• MADRS score between 14 and 22
• Patients with residual symptoms as assessed by MADRS items
• No cognitive impairment.
• Right-handed

Exclusion Criteria

• Subjects with legal incapacity or limited legal capacity
• Subjects unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
• Pregnant women
• Subjects in the exclusion period of another study or is on the "national volunteer list".
• Subjects with another psychiatric pathology (bipolar mood disorder, psychosis, obsessive-compulsive disorder, addictive pathology, schizophrenia)
• Subjects under a protective measure such as guardianship or safeguard of justice.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Neurofeedback sessions	10 neurofeedback sessions + depressive rating scales

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission	Week 10	Reduction in MADRS score to \< 8 (complete remission) after 10 neurofeedback sessions, in particular cumulative score less than or equal to 2 for hedonic and fatigue dimensions

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besançon, France