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Fragile X Syndrome (FXS)IMAGINERNCT06868979

Optical Imaging in X-linked Disorders.

A study testing Clinical assessment, Parental questionnaires and Cognitive assessment in people with Fragile X Syndrome (FXS) and Creatine Transporter Deficiency, run by Hospices Civils de Lyon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Fragile X syndrome (FXS, OMIM #300624) and Creatine Transporter Deficiency (CTD, #300352) are the two most common causes of X-linked intellectual disability. FXS and CTD affect hemizygous males and with highly variable severity heterozygous females. Read more about this study

Who is it for?
Ages 5 to 60 yearsHealthy volunteers can take part
What is being tested?
Clinical assessment, Parental questionnaires and Cognitive assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteFrance
Study dates
30 Mar 2026to Mar 2029
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 5 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • CTD male patients :
  • male
  • having a confirmed mutation in the SLC6A8 gene
  • ≥ 5 to ≤ 35 years old
  • whose maternal language is French,
  • having signed the informed consent and/or for whom parents (for children)/legal guardian (for protected adults) have signed the informed consent.
Show all 33Show fewer
  • affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system
  • CTD female patients :
  • female CTD patients having a confirmed mutation in the SLC6A8 gene,
  • aged > 5 to < 60 years,
  • whose maternal language is French (for the patients included in France),
  • having signed the informed consent and/or for whom parents (for children)/legal guardian (for protected adults) have signed the informed consent.
  • affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system
  • FXS patients :
  • male
  • having a confirmed full mutation in the FMR1 gene (>200 GCC repeats)
  • ≥ 5 to ≤ 35 years old
  • whose maternal language is French,
  • having signed the informed consent and/or for whom parents (for children)/legal guardian (for protected adults) have signed the informed consent.
  • affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system
  • Sex- and chronological age-matched male controls :
  • male
  • ≥ 5 to ≤ 35 years old
  • whose maternal language is French,
  • having signed the informed consent and/or for whom parents have signed the informed consent.
  • affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system
  • Sex- and chronological age-matched female controls :
  • female,
  • aged > 5 to < 60 years
  • whose maternal language is French (for the patients included in France),
  • having signed the informed consent and/or for whom parents/legal guardian have signed the informed consent.
  • affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system.
  • Each CTD patient will be matched to a sex- and chronological age-matched control.

Who cannot join

  • CTD male and female patients :
  • Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
  • Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.
  • FXS patients :
  • Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
  • Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.
Show all 12Show fewer
  • Sex- and chronological age-matched male and female controls :
  • Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
  • Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.
  • History of neurological or psychiatric disorder,
  • Repetition of a grade,
  • Learning disability requiring rehabilitation (speech therapy, psychomotor or oculomotor therapy).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Woman, mother and child hospital, Hospices Civils de Lyon

    Bron, 69500

    Aurore Curie, Dr, +33 6 70 62 69 76, Aurore.curie@chu-lyon.fr

    Aurore Curie, Dr

    Recruiting

Other trials in France

About this study

Official title: Optical Imaging as a Diagnostic Tool for Monitoring Brain Function in X-linked Rare Disorders

Fragile X syndrome (FXS, OMIM #300624) and Creatine Transporter Deficiency (CTD, #300352) are the two most common causes of X-linked intellectual disability. FXS and CTD affect hemizygous males and with highly variable severity heterozygous females. Both these neurodevelopmental disorders (NDDs) have a dramatic impact on the family quality of life and the health-care system. These disorders share common clinical traits, including intellectual disability, autistic-like features, behavioural and mood alterations and seizures. Brain anatomy appears largely normal, suggesting that functional deficits result from subtle changes in synaptic connectivity. Moreover, common physiological mechanisms related to brain energetics might concur to the pathophysiology of FXS and CTD. Indeed, FMR1 and SLC6A8 are directly involved in the regulation of metabolism and the loss-of-function of both genes leads to a disruption of the mitochondrial network.

There is no cure for these disorders and the efficacy study of potential treatments is hindered by the scarcity of unbiased, quantitative, non-invasive biomarkers for monitoring brain function.

Read more

This is a critical problem, since the often-used phenotypic observation of behavioural endpoints to score NDDs such as FXS and CTD is highly prone to subjective bias. For successful clinical trials, the availability of objective readouts is crucial to evaluate the therapeutic response to new drugs. There are multiple techniques to visualize neural circuit activity in the living brain. Interestingly, FXS and CTD are the only two NDDs that at preclinical level show an abnormally large hemodynamic response to sensory stimulation in functional imaging studies of intrinsic optical signals.

The objective of this project is to exploit optical imaging techniques to devise a measurable and non-invasive biomarker of brain function in FXS and CTD. Since a disruption of brain energy metabolism is a major disease mechanism linking these disorders, we hypothesized that the assessment of the cerebral blood flow and oxygen consumption represents a sensitive readout for quantifying functional alterations of neural circuits.

Functional near-infrared spectroscopy (fNIRS), allows quantifying changes of hemoglobin species and local blood flow in the cerebral cortex of humans, providing an indirect measure of neuronal activity. In the clinical framework, this blood-oxygen-level-dependent signal is similar to that detected with functional MRI (fMRI). However, fNIRS has the advantage of being completely non-invasive, low-cost, portable, noiseless, endowed with high experimental flexibility and easy to implement in both laboratory and clinical settings. Moreover, fNIRS is more tolerant to motion artifacts than fMRI, and robust methods for motion detection/correction allow to image very young children without sedation. These methodological strengths make fNIRS as an outstanding choice for investigating neural circuits in clinically relevant populations at the very-low cost. Although introduced into the clinical care almost 40 years ago, fNIRS gained much popularity in the study of brain development and NDDs only recently. To date, however, fNIRS has been used primarily to investigate the typical maturation of speech perception and language, sensory and motor functions, social communication and interaction, object and action processing in toddlers and children.

In this proposal, the investigators hypothesize that by combining the above-mentioned strengths of fNIRS to the clinical study of several cognitive and motor parameters, the investigators can define unique "fNIRS signatures" for FXS and CTD as brain biomarkers for the diagnosis and the assessment of treatment outcomes. Since the measurement of visual responses has been introduced as a quantitative method to assess brain function in NDDs, the investigators will test the value of visually-evoked fNIRS signals in classifying patients and predicting symptom severity in the FXS and CTD clinical population. Preliminary data in the mouse models of CTD and FXS strongly suggest that visual hemodynamic responses (vHDR) are markedly altered in the occipital cortex of mutant animals. Morever, the investigators will use a standardized procedure with high entertaining value to measure vHDR in the occipital cortex of children.

Being tested
Clinical assessment, Parental questionnaires, Cognitive assessment, Reasoning assessment, fNIRS assessement
Keywords
Fragile X syndrome, Optical imaging, brain function, Creatine transporter, cognitive function, reasoning tasks
Medical subject headings
Fragile X Syndrome, Creatine deficiency, X-linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical assessmentOther

    Clinical examination including Medical history, developmental trajectory, epilepsy history, ASD symptoms, clinical examination at the inclusion visit by a neuropediatrist

  • Parental questionnairesOther

    Parental questionnaires including Vineland-2, ABC, CBCL, PPD-MRS, SRS-2 and BRIEF completed at the inclusion visit

  • Cognitive assessmentOther

    Cognitive assessment including Leiter-3, PPVT 5, EVT 3 completed at the inclusion visit

  • Reasoning assessmentOther

    Simple reasoning tasks on tablets performed at the inclusion visit.

  • fNIRS assessementDevice

    Imaging session using fNIRS (NIRSport 8x8, NIRx Medical Technologies LLC, Berlin, Germany) performed at the inclusion visit.

Study groups in NCT06868979
Study groupRoleWhat they receive
Male CTD (Creatine Transporter Deficiency ) patientsOtherMale CTD patients having a confirmed mutation in the SLC6A8 gene, aged > 5 to < 35 years.
Receives: Other: Clinical assessment; Other: Parental questionnaires; Other: Cognitive assessment; Other: Reasoning assessment; Device: fNIRS assessement
FXS (Fragile X Syndrome) patientsOtherMale FXS patients having a confirmed full mutation in the FMR1 gene (>200 GCC repeats), aged > 5 to < 35 years.
Receives: Other: Clinical assessment; Other: Reasoning assessment; Device: fNIRS assessement
Sex and Chronological age-matched male controlsOtherMale aged > 5 to < 35 years.
Receives: Other: Clinical assessment; Other: Parental questionnaires; Other: Cognitive assessment; Other: Reasoning assessment; Device: fNIRS assessement
Female CTD (Creatine Transporter Deficiency ) patientsOtherFemale CTD patients having a confirmed mutation in the SLC6A8 gene, aged > 5 to < 60 years.
Receives: Other: Clinical assessment; Other: Parental questionnaires; Other: Cognitive assessment; Other: Reasoning assessment; Device: fNIRS assessement
Sex and Chronological age-matched female controlsOtherFemale aged > 5 to < 60 years.
Receives: Other: Clinical assessment; Other: Parental questionnaires; Other: Cognitive assessment; Other: Reasoning assessment; Device: fNIRS assessement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amplitude of the visual hemodynamic response

    Cortical hemodynamic activity data recorded via fNIRS imaging in response to visual stimulation (task-evoked) using a cartoon-based stimulus. Measure of the amplitude of the peak response to viewing radial checkerboard blended with the animated cartoon for total Hb, OxyHb and DeoxyHb concentration change.

    Measured: Inclusion visit

  2. Latency of the visual hemodynamic response

    Cortical hemodynamic activity data recorded via fNIRS imaging in response to visual stimulation (task-evoked) using a cartoon-based stimulus. Measure of the latency of the peak response to viewing radial checkerboard blended with the animated cartoon for total Hb, OxyHb and DeoxyHb concentration change.

    Measured: Inclusion visit

Secondary outcomes (16)
  1. Clinical Endpoints_Presence of epilepsy

    Presence of epilepsy

    Measured: Inclusion visit

  2. Clinical Endpoints_Type of epilepsy

    Type of epilepsy

    Measured: Inclusion visit

  3. Clinical Endpoints_Treatment of epilepsy

    Antiepileptic treatment (if any)

    Measured: Inclusion visit

  4. Clinical endpoints_Developmental trajectory

    Age at walking, Age at first words, Age at 2 words association, Age at first sentences

    Measured: Inclusion visit

  5. Clinical endpoints_Autism spectrum disorder (ASD)

    Autism spectrum disorder (ASD) diagnosis (using DSM5 criteria)

    Measured: Inclusion visit

  6. Cognitive assessment with Leiter 3 scale

    Score of the cognitive assessment obtained with the Leiter 3 scale (4 cognitive sub-tests to be able to compute the non-verbal IQ and 2 non-verbal memory sub-tests)

    Measured: Inclusion visit

  7. Cognitive assessment with Bayley 4 scale

    Score of the cognitive assessment obtained with Bayley 4 scale (if Leiter 3 scale is not possible)

    Measured: Inclusion visit

  8. Language assessment with the PPVT-5 test

    Score obtained with the PPVT-5 (Peabody Picture Vocabulary Test Fifth Edition) test for receptive vocabulary

    Measured: Inclusion visit

  9. Language assessment with the EVT-3 test

    Score obtained with the EVT-3 (Expressive Vocabulary Test third edition) test for expressive vocabulary.

    Measured: Inclusion visit

  10. Reasoning tasks

    Simple reasoning tasks on tablet (with four difficulty levels, A to D: match-to-sample task, categorization task, analogical reasoning task, implicit rules tasks). Reaction Time (RT) and Error Rate (ER) will be anayzed for each of the four reasoning tasks. The RT is defined as the time elapsing between the display of the image and the time when the subject selected one of the two answers.

    Measured: Inclusion visit

  11. Parental questionnaires to assess adaptive abilities (Vineland 2)

    Parental questionnaires to assess adaptive abilities (Vineland 2)

    Measured: Inclusion visit

  12. Parental questionnaires to assess behavioral disorder (ABC 2)

    Parental questionnaires to assess behavioral disorder (ABC 2)

    Measured: Inclusion visit

  13. Parental questionnaires to assess behavioral disorder (CBCL)

    Parental questionnaires to assess behavioral disorder (CBCL)

    Measured: Inclusion visit

  14. Parental questionnaires to assess autistic features (PDD-MRS)

    Parental questionnaires to assess autistic features (PDD-MRS)

    Measured: Inclusion visit

  15. Parental questionnaires to assess autistic features (SRS2)

    Parental questionnaires to assess autistic features (SRS2)

    Measured: Inclusion visit

  16. Parental questionnaires to assess executive functions (BRIEF)

    Parental questionnaires to assess executive functions (BRIEF)

    Measured: Inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start30 Mar 2026
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is a multicentric prospective, cross-sectional case control study to determine biomarkers to be used in future clinical trials in CTD and FXS patients.
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868979
Sponsor's protocol ID
69HCL23_0409
Other IDs
2024-A01730-47
Acronym
IMAGINER
Status last verified
May 2026
First submitted
14 Feb 2025
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical assessment, Parental questionnaires and Cognitive assessment in people with Fragile X Syndrome (FXS) and Creatine Transporter Deficiency, run by Hospices Civils de Lyon 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 33 inclusion and 12 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 15 May 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 Aurore CURIE, Dr (+336 70 62 69 76, Aurore.curie@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amplitude of the visual hemodynamic response (time frame: Inclusion visit). 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 15 May 2026.

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