Not Yet Recruiting

NCT Number: NCT06817980

Disorders of the Sense of Self and Physical Activity

Schizophrenia (SZ) patients with metabolic syndrome, patients with vestibular syndrome, and patients with borderline personality disorder, would benefit from physical activity (PA). Yet patient adherence to PA is low, at least in the case of SZ. the investigators work and the literature lead the investigators to consider that, in addition to motivational aspects, disorders of the bodily sense of self could play a role in this lack of adherence. Simply walking involves visual movements related to the self, which must be distinguished from movements in the environment. This means a distinction between self and not-self. Furthermore, these movements are all the more difficult to distinguish as they may also result from the fact that hidden objects become visible as a result of our own movement. In all sense-of-self disorders can themselves affect physical training, and the investigators will measure them in the first stage. In the second stage, the investigators will apply a standard, risk-free PA protocol by walking (3x3 sessions of 30 min). the investigators will test the impact of physical training on the sense of self under different conditions, with one environment minimizing self-related movement, vs. 2 environments with a variable level of enrichment (i.e. hidden objects inducing more or less self-related movement).

At the end of the protocol, the investigators will offer participants who wish to take part in an ancillary study, i.e. a walking session with mixed-reality goggles. These will superimpose a luminous flux on the periphery of the visual field. According to results obtained in the laboratory, this flux could restore sensory mechanisms impaired in schizophrenia. the investigators will use these glasses in the most difficult condition for the patient, and verify their impact.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

SCHIZOPHRENIA 1 (Disorder) Borderline Personality Disorder Mental Disorders Personality Disorders Vestibular Syndromes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de psychiatrie

Strasbourg, 67000, France

Location contact

Anne GIERSCH, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Criteria common to all participants:
Men or women aged 18 to 60 inclusive
Subject affiliated to a health insurance scheme, beneficiary or beneficiary's beneficiary
Able to understand the aims and risks of the research, and to give informed consent
Visual acuity > 0.7 on the Freiburg Vision Test (Bach 1996) due to the use of visual equipment
BMI (body mass index) < 40 (due to cardiovascular risk).

Patient-specific criteria:

With schizophrenia: criteria for schizophrenia as defined in the DSMV (American Psychiatric Association, 2015)
With borderline personality disorder: criteria for borderline personality disorder as defined in the DSMV (American Psychiatric Association, 2015)
With vestibular disorders: peripheral vestibular disorders established after otolaryngological examination

Exclusion criteria

Criteria common to all participants:
Serious or unstabilized somatic pathology (including cardiovascular)
History likely to affect cerebral anatomy or to be linked to an abnormality (neonatal suffering, neurosurgical operation, comitiality, stroke...)
Presence of joint pain, likely to worsen after exercise
- Substance use disorders (as defined by DSM-IV TR)
3D vision disorders as measured by the Wirt stereotest (depth perception at a disparity of at least 80'' arc)
Movement perception disorders (correct movement discrimination in less than 75% of trials (cf. § V-2.2)
History of general anaesthesia in the 3 months preceding the study
History of neurological disease
Impossibility of giving the subject informed information (subject in emergency situation)
Pregnancy declared by patient
Breast-feeding
Subject in exclusion period (determined by a previous or current study)
Subject hospitalized
Subject under court protection

Exclusion criteria

specific to control subjects or patients with vestibular syndrome:

History of major psychiatric pathology with current psychotropic medication (i.e., antidepressant, thymoregulator, antipsychotic)

Treatment and study plan

Physical activity

Behavioral

Physical activity: We will compare the impact of 3 different environments (with no object in the environment, vs. with some objects but no hidden objects vs. with objects at the fore- and background) during (total of 9 sessions of 30 minutes + 3*5 minutes of testing), on the measure of self (see below).

Visit 10: We will repeat a walking session. Participants will wear mixed-reality goggles, which allow them to visualize the environment and superimpose a continuous stream of light. This session is intended to test the idea that this flow would enable SZ patients to suffer less from the discontinuous appearance of information when moving around.

Measure of 'self' : the participants will decide whether the line presented on a computer screen is static or moving. They will be immobile, walking on the spot in front of the computer, or passively mobilized with a whole-body movement platform. The latter condition will be used only in the first phase of the protocol

Primary outcomes

Impact of physical activity on the 'self' measure

Time frame: Day 0

Quantification of the d' index, which represents the ability to discriminate between moving and static lines (whose movement is only related to one's own displacement, which induces a mirror movement on the retina). The d' will be measured three times per PA session, and in all 3 sessions per condition (neutral vs. enriched, with increasing complexity of self-related movements).

The evaluation criterion will be the evolution of the d' index over the course of the PA training sessions in the 3 conditions.
Impact of physical activity on the 'self' measure

Time frame: between Day 0 and Month 3

Quantification of the d' index, which represents the ability to discriminate between moving and static lines (whose movement is only related to one's own displacement, which induces a mirror movement on the retina). The d' will be measured three times per PA session, and in all 3 sessions per condition (neutral vs. enriched, with increasing complexity of self-related movements).

The evaluation criterion will be the evolution of the d' index over the course of the PA training sessions in the 3 conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Teletin, MD

CONTACT

[email protected]

Sarah Hustache

CONTACT

[email protected]

0388116768

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: sensdesoi

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Feb 10, 2025
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting