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

R

Regional University Hospital Center (CHRU)

Status

Not yet enrolling

Conditions

Depression
Virtual Reality

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT07119008
29BRC23.0272 - REVIVED

Details and patient eligibility

About

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.

Full description

Every patient diagnosed with depression receives psychotropic treatment comprising one or more antidepressants, possibly combined with one or more thymoregulators (e.g. bipolar patients), one or more anxiolytics and/or a hypnotic. The elderly depressive patient is also treated with supportive psychotherapy and/or group therapy at the day hospital. The trial proposes an additional tool, virtual reality, aimed at improving the cognitive abilities, particularly executive abilities, of the elderly depressive subject, thereby helping to maintain his or her functional abilities, i.e. his or her ability to stay as autonomous as possible at home and maintain a good quality of life. In fact, cognitive disorders associated with depression do not respond to antidepressant medication, if at all. It therefore seems important to optimize the treatment of depression in the elderly subject by adding a cognitive target. The investigators's project is to offer patients the opportunity to live in a virtual kitchen, where they can carry out everyday tasks. The scenario for the VR sessions has been designed in collaboration with, the principal investigator at CHU and his team, and the members of B COM and HDG involved in the study. Particular attention is paid to the fact that this scenario is intended for an elderly patient population, so as to prevent as far as possible the occurrence of cybermalaise The patient will be asked to arrange food shopping appropriately, differentiating between perishable and non-perishable foodstuffs and non-food items, or to prepare cooking recipes. Virtual reality has the advantage of being able to offer ecological, configurable activities, targeting precise tasks that call on executive functions such as initiative, anticipation and planning, mental flexibility and inhibition. Patients will undergo 12 VR sessions at a rate of 2 sessions per week for 6 weeks.

Enrollment

40 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 70 or over;
  • Patient with a characterized depressive episode as assessed by the GDS (Score > 13 at inclusion);
  • Patient with a minimum MMS score of 23/30 at inclusion;
  • 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.

Exclusion criteria

  • 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.
  • Patients who do not speak or read French fluently, unable to understand the principle of the study questionnaires and unable to cooperate with the tests.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

use of virtual reality
Experimental group
Treatment:
Device: Virtual reality

Trial contacts and locations

1

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Central trial contact

Sophie LE BORGNE, Dr

Data sourced from clinicaltrials.gov

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