Demyelinating DiseaseNCT03010826
Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children
An observational study of Demyelinating Disease, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Demyelinating Disease
- How many people
- 78 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2016to 16 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: There will be a total of 80 participants in this study. The study population consists of both patients (demyelinating disease) and non-patient participants (healthy volunteers).
Who may be able to join
- Experienced a demyelinating event (Only applicable to patient subjects)
- Between the ages of 5 years to 18 years and 11 months of age
- Has either English as his or her native language or has had at least two years of schooling in English
Who cannot join
- Children with non-demyelinating etiologies of white matter dysfunction (i.e., metabolic disorders, vasculitis, and non-specific MRI abnormalities
- Is younger than 5 years of age
- Is 18 years and 11 of age or older
- Has a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay, or learning disability
- Requires sedation for brain scanning
- Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI machine
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen's University
Kingston, Ontario, K7L 3N6
Hospital for Sick Children
Toronto, Ontario, M5G1X8
About this study
The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and cognitive problems. Currently there are no effective medical therapies to promote brain repair and reduce disability following damage to white matter. In this project, we hope to change the situation by encouraging the brain itself to generate new oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to white matter growth.
- Conditions
- Demyelinating Disease
- Medical subject headings
- Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 40 Demyelinating Disease patients | Not described | |
| 40 Non-patient participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal responses during pro/anti-saccade eye movements
Video-based eye tracking monocularly in the MEG and binocularly outside the MEG
Measured: 60 minutes
Electrical potentials initiated by brief visual stimuli
Visual Evoked Potentials (VEP)
Measured: 10 minutes
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
Measured: 90 minutes
Neurocognitive Testing
Computerized Penn Neurocognitive Battery
Measured: 90 minutes
High contrast visual acuity
Measured: 10 minutes
Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
Measured: 10 minutes
Colour vision testing
Measured: 10 minutes
Visual fields testing
Measured: 20 minutes
Optical coherence tomography (OCT)
Measured: 25 minutes
Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
Measured: 20 minutes
Clinical Interview
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demyelinating DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Ann Yeh, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010826
- Sponsor's protocol ID
- 1000053920
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children
- ClinicalTrials.gov ID
- NCT03010826
- Acronym / sponsor ID
- 1000053920
- Conditions
- Demyelinating Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and cognitive problems. Currently there are no effective medical therapies to promote brain repair and reduce disability following damage to white matter. In this project, we hope to change the situation by encouraging the brain itself to generate new oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to white matter growth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 Demyelinating Disease patients | – | – |
| 40 Non-patient participants | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- There will be a total of 80 participants in this study. The study population consists of both patients (demyelinating disease) and non-patient participants (healthy volunteers).
Key inclusion criteria (3 listed)
- Experienced a demyelinating event (Only applicable to patient subjects)
- Between the ages of 5 years to 18 years and 11 months of age
- Has either English as his or her native language or has had at least two years of schooling in English
Key exclusion criteria (6 listed)
- Children with non-demyelinating etiologies of white matter dysfunction (i.e., metabolic disorders, vasculitis, and non-specific MRI abnormalities
- Is younger than 5 years of age
- Is 18 years and 11 of age or older
- Has a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay, or learning disability
- Requires sedation for brain scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuronal responses during pro/anti-saccade eye movements
Time frame: 60 minutes
Video-based eye tracking monocularly in the MEG and binocularly outside the MEG
Electrical potentials initiated by brief visual stimuli
Time frame: 10 minutes
Visual Evoked Potentials (VEP)
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
Time frame: 90 minutes
Neurocognitive Testing
Time frame: 90 minutes
Computerized Penn Neurocognitive Battery
High contrast visual acuity
Time frame: 10 minutes
Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
Time frame: 10 minutes
Colour vision testing
Time frame: 10 minutes
Visual fields testing
Time frame: 20 minutes
Optical coherence tomography (OCT)
Time frame: 25 minutes
Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
Time frame: 20 minutes
Clinical Interview
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Demyelinating Disease, run by The Hospital for Sick Children at 2 sites in Canada.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuronal responses during pro/anti-saccade eye movements (time frame: 60 minutes). The study lists 11 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 7 Jan 2020.