Gilenya's Impact on Cognitive Function and Thalamic Volumes
Impact of Gilenya on Cognitive Function and Thalamic Volume Measured by 7 Tesla MRI in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- 7T MRI
- Neurocognitive testing
What it measured
Main measures
Thalamic volume to cognitive performance
One year.
Brain volume lossThinking and memory
Other measures (7)
Thalamic volume to other MRI metrics
Six months and one year.
MRI lesionsBrain volume lossThalamic nuclei to cognitive performance
Six months and one year.
Thinking and memoryThalamic myelin density to cognitive performance
Six months and one year.
Thinking and memoryThalamic axon density to cognitive performance
Six months and one year.
Thinking and memoryChanges in MRI metrics in Gilenya treated patients vs. controls
Six months and one year.
MRI lesionsBrain volume lossChanges in cognitive performance in Gilenya treated patients vs controls
Six months and one year.
Thinking and memoryThalamic volume to cognitive performance
Six months.
Brain volume lossThinking and memory
Who could take part
Relapsing MS · 18 to 50 · EDSS 0 to 4.0
Show the full criteria
Inclusion criteria
Inclusion Criteria (MS Patients): 1. RRMS phenotype 2. Treated with Gilenya for ≥6 months at the time of the baseline visit. 3. Age 18-50 inclusive. 4. EDSS 0-4.0 5. Disease duration of 5-15 years. 6. At least 12 years of education (high school diploma or general equivalency diploma). 7. Physically capable of completing neurometric testing and MRI studies. Inclusion Criteria (Healthy Controls): 1. Age 18-50 inclusive. 2. At least 12 years of education (high school diploma or general equivalency diploma) 3. Physically capable of completing neurometric testing and MRI studies. Exclusion Criteria (MS Patients): 1. Contraindication to MRI (e.g. metal implants) 2. Current use of immunomodulatory or immunosuppressant medications other than Gilenya. 3. Disease of the central nervous system other than MS (e.g. Alzheimer disease, stroke, epilepsy). 4. Use of anti-psychotic or psychostimulant medications. Patients started on modafinil or armodafinil more than six months prior to enrollment will not be excluded. 5. Ongoing major depressive disorder that, in the opinion of the investigator, may affect cognitive functioning. 6. MS relapse within 90 days of study entry. 7. Treatment with corticosteroids within 90 days of study entry. 8. Current illicit substance use. 9. History of alcohol or drug abuse. Exclusion Criteria (Healthy Controls): 1. Contraindication to MRI (e.g. metal implants, claustrophobia). 2. Disease of the central nervous system (e.g. MS, Alzheimer disease, stroke, epilepsy). 3. Use of anti-psychotic or psychostimulant medications. Patients started on modafinil or armodafinil more than six months ago will not be excluded. 4. Ongoing major depressive disorder that, in the opinion of the investigator, may affect cognitive functioning. 5. Current illicit substance use. 6. History of alcohol or drug abuse.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This evaluation will be a one-year feasibility study to characterize the neuroprotective benefits of Gilenya and its effects on cognition and grey matter volumes. The study will enroll 15 patients with relapsing-remitting multiple sclerosis being treated with Gilenya and 5 healthy controls. Each participant will undergo a battery of neurometric testing at baseline, six months, and one year. In addition, patients will undergo high-field 7T MRI at the same time points.
Papers
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History
Started
Oct 2017
Main results due
Nov 2019
Finished
Nov 2019