Use of Virtual Reality as a Tool for Cognitive Remediation in Elderly Depressed Patients

NCT07119008 | Not Yet Recruiting

• 1 other identifier: 29BRC23.0272 - REVIVED
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Depression, the most common mental disorder affecting the elderly, represents a major public health issue. This pathology leads to a loss of activity and autonomy in the elderly. It impairs executive skills, enabling a person to take initiatives, perform goal-oriented actions and adapt to new situations. Impaired executive functions greatly increase the risk of loss of autonomy and institutionalization, as well as the burden on caregivers. Antidepressant treatments have little or no effect on cognitive disorders. It therefore appears necessary to offer these patients specific treatment of these cognitive symptoms. The investigators are interested in cognitive remediation based on virtual reality (VR) for its ecological and modular characteristics, the innovative aspect of this technique, the appeal of virtual experiences, and their easy access to the general public. The main objective of this study is to demonstrate the acceptability of the VR technique in a population of subjects aged 70 and over, suffering from cognitive disorders and associated depression. In this study the investigators support the use of VR as a tool for cognitive remediation and ecological staging of their interactions with caregivers in the face of executive disorders found in patients suffering from depression. By improving their cognitive skills, VR brings greater autonomy and improved quality of life for patients and their caregivers. The investigators therefore plan to use a virtual environment to create scenarios that reproduce real-life situations, which appear to be more relevant than conventional cognitive remediation exercises. The investigators chose acceptability as the main criterion for this technique, as the elderly population is identified as a sensitive population in the opinion issued by ANSES in June 2021. What's more, this population is often excluded from the new digital technologies; it therefore seems interesting to look at the acceptability of virtual reality by this elderly population.

Conditions

Virtual Reality; Depression

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

• The acceptability of Virtual Reality

  Virtual Reality acceptability will be assessed using the French version of the Acceptability E-scale questionnaire at the end of session 12. A success/failure criterion will be defined by setting the cut-off point at 24 out of 30. The questionnaire will also be completed at the end of sessions 1 and 6, to provide usable information should a patient withdraw from the protocol prematurely for any reason other than refusal to continue the study. A patient who decides to stop the virtual reality sessions before the 12th session will be considered as a failure.

  at the end of session 12, on average in Week 6

Secondary Outcomes (9)

• TERV tolerance

  at the end of the sessions, on average in Week 6

• The impact of TERV on depressive symptomatology

  at inclusion and at the end of the 12 sessions, on average in Week 6

• The impact of TERV on quality of life

  at inclusion and at the end of the 12 sessions, on average in Week 6

• The impact of TERV on executive disorders

  at inclusion and at the end of the 12 sessions, on average at Week 6

• The impact of TERV on executive disorders

  At inclusion and at the end of the 12 sessions, on average at Week 6

Study Arms (1)

use of virtual reality

EXPERIMENTAL

Device: Virtual reality

Interventions

Virtual reality DEVICE

Patients will perform 12 virtual reality sessions at a rate of 2 sessions per week for 6 weeks. The patient will be offered to properly store food groceries by differentiating perishable or non-perishable foods from non-food items, or to prepare cooking recipes.

use of virtual reality

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 70 or over;
• Patient affiliated to or benefiting from a social security scheme;
• Patient having received information on the protocol and having given free, informed and written consent.

You may not qualify if:

• Patients suffering from epilepsy;
• Patients suffering from inner ear disorders;
• Patients with balance disorders or postural instability;
• Patients with swallowing disorders requiring mixed feeding;
• Patients suffering from migraines;
• Patients with major sensory deficits (visual or auditory);
• Patients suffering from eye pathologies or abnormalities, and whose condition strictly contraindicates virtual reality;
• Patients suffering from oculo-motor disorders;
• Patients with sensory-motor deficits affecting the upper limb(s) that prevent them from performing the tasks required during VR sessions;
• Patients suffering from primary neuropathic disorders or secondary to metabolic pathologies;
• Patients suffering from acute psychiatric decompensation that makes it impossible for them to cooperate with the sessions (opposition, agitation, acute delusions, hallucinations, panic attacks);
• Patients with uncontrolled cardiac pathology (angina, heart failure, rhythm disorders, conduction disorders);
• Patients with uncontrolled hypertension (SBP \> 140 mmHg and DBP \> 90 mmHg in patients with traited hypertension);
• Patients with implanted medical devices (pacemakers, defibrillators, etc.);
• Patients under legal protection (guardianship) or deprived of liberty.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU Brest - Hôpital de Bohars

Bohars, 29820, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sophie LE BORGNE, Dr

  CHU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie LE BORGNE, Dr

CONTACT

+33 2 98 01 50 27; sophie.leborgne@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical investigation of a Class I medical device. Early interventional, uncontrolled, single-center, unblinded trial.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)