Clinical Impact and Neuro-functional Substrate of Immersive Virtual Reality Sports Practice on Depression

NCT05019183 | Unknown

• 2 other identifiers: 2020PBMD052020-A03415-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

Depression is a major public health issue due to its frequency (prevalence of 7.5% in adults), its difficulties in therapeutic management (ineffective in 30% of cases and poor compliance) and its societal cost (170 billion euros per year). The most frequent clinical expression is a characterized depressive episode. Physical activity, through better management of emotions and stress, has been proposed as a complementary therapeutic approach in depression. Studies have shown a decrease in depressive symptoms during a sports program of at least 2 weeks in addition to pharmacological treatment. Similarly, mindfulness meditation, because it reduces ruminations, could also improve the therapeutic management of depression. More recently, virtual reality (VR) exposure therapy has also been proposed in the treatment of anxiety and depression, with a benefit of multisensory stimulation induced by a virtual environment in cognitive and sensory-motor rehabilitation and emotion regulation. However, these therapeutic strategies, in addition to pharmacological treatments, have limits. There is thus a real challenge in designing innovative therapeutic programs for the treatment of depression that encourage motivated practice. A sports activity coupled with immersion in VR could combine the benefits of each of these treatments. With the emergence of new immersive technologies, VR allows the recreation of sensory experiences in an environment close to the ecological context. The use of physical activity on an indoor rower or other sensor-equipped device could thus intensify the psychological benefits of exercise and improve compliance. However, there is a lack of clinical evidence to recommend this coupled therapeutic approach in the additional treatment of depression. This approach is part of the embodied virtual medicine road map. Furthermore, a better understanding of the biological, metabolomic, and cerebral mechanisms underlying this approach could improve its effectiveness. It would make it possible to propose and evaluate biomarkers for therapeutic and prognostic monitoring of depression. In particular, progress in the field of the "-omics" family includes new tools with great potential. This is more specifically the case of metabolomics. The analysis of metabolites present in the organism or released with natural secretions would allow to constitute a metabolomic signature evolving during the treatment. The interest in characterizing metabolomic biomarkers is an interesting avenue to meet the need to establish a biological diagnosis with quantified values, for better objectivity and follow-up. Functional imaging could also be used to highlight regional activity or connectivity anomalies and markers of response to therapy in relation to biology. The aim of this work is to determine the clinical impact of physical exercise in VR on a depressive state, and to study in biology, metabolomics and neuroimaging the functional substrates of such a practice in order to understand the mechanisms involved and to propose ways to improve the management of depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in the Questionnaire Inventory of Depressive Symptomatology (QIDS-SR) depression scale score between Day 1 and Day 10

  This questionnaire is built on the 9 symptoms used in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5): sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decreased/increased appetite or weight, and psychomotor slowing/agitation. The total score ranges from 0 to 27 with higher scores meaning higher levels of depression.

  From Day 1 to Day 10

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients in the experimental arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) during which they will be able to move freely in a virtual environment.

Other: Physical training; Other: Virtual reality; Device: Single-photon emission computed tomography (SPECT); Biological: Metabolomics

Control arm

OTHER

Patients in the control arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) without being exposed to a virtual environment.

Other: Physical training; Device: Single-photon emission computed tomography (SPECT); Biological: Metabolomics

Interventions

Physical training OTHER

The subjects will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) with a target heart rate zone of 60%.

Control arm; Experimental arm

Virtual reality OTHER

The subjects will be able to move freely in virtual environments while training on the indoor rower.

Experimental arm

Single-photon emission computed tomography (SPECT) DEVICE

SPECT allows the measurement of cerebral perfusion, reflecting the global synaptic activity, via a 3D acquisition of 20 minutes, 15 minutes after injection of 740 MBq of radiotracers (ECD - Neurolite or HMPAo - Cerestab), with iterative reconstruction. The data will be processed at the voxel scale by the SPM12 software, with analysis of brain connectivity.

Control arm; Experimental arm

Metabolomics BIOLOGICAL

This qualitative approach will aim to identify pathways that are not known (or have not been explored) to optimize the chances of detecting metabolites present depending on the group (physical activity coupled or not with VR). This method is favorable for biomarker discovery.

Control arm; Experimental arm

Eligibility Criteria

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

You may qualify if:

• patients between the ages of 18 and 65
• with a diagnosis of characterized depressive episode according to the DSM-5 criteria
• able to practice indoor rower.

You may not qualify if:

• Pregnant or breastfeeding women
• With major depression as part of bipolar affective disorder
• Presence of a suicidal risk
• Under Cognitive behavioral therapy or whose medication has been modified in the month preceding enrollment
• History of neurological pathology, head injury or mental retardation
• Presence of an addictive comorbidity
• Presence of a major organic pathology
• Presence of a contraindication to virtual reality exposure
• Presence of a contraindication to SPECT
• Presence of a predisposition to discomfort caused by mobile environments

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (3)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

CHU La Conception

Marseille, 13005, France

Location

Institut Fresnel, CERIMED

Marseille, 13005, France

Location

MeSH Terms

Conditions

Depression

Interventions

Physical Conditioning, Human; Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Marion TROUSSELARD, MD, PhD

CONTACT

178651255; marion.trousselard@intradef.gouv.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into 2 arms: * Experimental arm: patients will beneficiate from a training program in an immersive environment (virtual reality) * Control group: patients will beneficiate from a training program in a real (non-virtual) environment

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 24, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

FR (3)