Clinical Impact and Neuro-functional Substrate of Immersive Virtual Reality Sports Practice on Depression
NCT ID: NCT05019183
Last Updated: 2021-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-09-30
2022-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental arm
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.
Physical training
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%.
Virtual reality
The subjects will be able to move freely in virtual environments while training on the indoor rower.
Single-photon emission computed tomography (SPECT)
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.
Metabolomics
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
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.
Physical training
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%.
Single-photon emission computed tomography (SPECT)
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.
Metabolomics
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.
Interventions
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Physical training
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%.
Virtual reality
The subjects will be able to move freely in virtual environments while training on the indoor rower.
Single-photon emission computed tomography (SPECT)
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.
Metabolomics
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.
Eligibility Criteria
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Inclusion Criteria
* with a diagnosis of characterized depressive episode according to the DSM-5 criteria
* able to practice indoor rower.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
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Locations
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Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, , France
CHU La Conception
Marseille, , France
Institut Fresnel, CERIMED
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Marion TROUSSELARD, MD, PhD
Role: primary
Raphaëlle RICHIERI, MD
Role: primary
Eric GUEDJ, MD, PhD
Role: primary
Other Identifiers
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2020-A03415-34
Identifier Type: OTHER
Identifier Source: secondary_id
2020PBMD05
Identifier Type: -
Identifier Source: org_study_id