SCHIZOPHRENIA 1 (Disorder)sensdesoiNCT06817980
Disorders of the Sense of Self and Physical Activity
A study testing Physical activity in people with SCHIZOPHRENIA 1 (Disorder) and Borderline Personality Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Borderline Personality Disorder, Vestibular Syndromes
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marius Teletin, MD contact
France1 site, 1 recruiting
- Recruiting
Service de psychiatrie
Strasbourg, 67000
Anne GIERSCH, MD, giersch@unistra.fr
About this study
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.
- Being tested
- Physical activity
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Self and physical activity protocol | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of physical activity on the 'self' measure
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.
Measured: Day 0
Impact of physical activity on the 'self' measure
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.
Measured: between Day 0 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start11 Aug 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817980
- Sponsor's protocol ID
- 9530
- Acronym
- sensdesoi
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disorders of the Sense of Self and Physical Activity
- ClinicalTrials.gov ID
- NCT06817980
- Acronym / sponsor ID
- sensdesoi / 9530
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self and physical activity protocol | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity- 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 | Behavioural | Self and physical activity protocol |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Not yet recruitingPhase 3
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
SCHIZOPHRENIA 1 (Disorder)
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Not yet recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2
SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marius Teletin, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with SCHIZOPHRENIA 1 (Disorder) and Borderline Personality Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hustache (0388116768, dpidrci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of physical activity on the 'self' measure (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.