Multiple Sclerosis Clinical Trial
Official title:
Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis
Verified date | September 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary fatigue represents a major cause of disability in patients with multiple sclerosis (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning but, unfortunately, little is known about its mechanisms. The investigators propose a characteristic eye movement abnormality (internuclear ophthalmoparesis, INO), commonly encountered in MS, as a simple model for primary motor fatigue. The investigators described worsening of ocular performance in MS patients with INO following visual tasks (ocular motor fatigue), which is likely due to decreased neural conduction along brain pathways injured by MS. This mechanism could represent a major component of MS-related primary motor fatigue. Relevant to Veterans' care, INO is a significant cause of visual disability, especially when complicated by ocular fatigue, and limits daily activities such as reading and driving. The investigators propose a medical treatment to improve ocular performance/fatigue in INO, which can reduce visual disability and improve quality of life in Veterans with MS.
Status | Completed |
Enrollment | 23 |
Est. completion date | March 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of MS of any course and duration - Evidence of mild to moderate internuclear ophthalmoparesis (INO), that is slowing of the adducting eye on physical examination of saccadic speed, whether INO is unilateral or bilateral, symmetrical or asymmetrical - Medically stable conditions, ability to give informed consent and understand and cooperate with the testing - Dalfampridine-naive as well as history of taking dalfampridine in the past, whether there was benefit in gait impairment or not, after a washout period of at least 2 weeks Exclusion Criteria: - Lack of evidence of INO (slowing of the adducting eye) on physical examination of saccadic speed - Severe INO (i.e., exotropia in primary gaze) on physical examination - Medically unstable conditions, inability to give informed consent and understand and cooperate with the testing - History of side effects from dalfampridine - History of seizures - Moderate or severe renal failure, assessed by clearance of creatinine |
Country | Name | City | State |
---|---|---|---|
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Serra A, Chisari CG, Matta M. Eye Movement Abnormalities in Multiple Sclerosis: Pathogenesis, Modeling, and Treatment. Front Neurol. 2018 Feb 5;9:31. doi: 10.3389/fneur.2018.00031. eCollection 2018. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity. | For each saccade made by the subject, the ratio of the maximum velocity (deg/sec) of the eye moving away from the nose and of the eye moving towards the nose was calculated. Subjects' horizontal saccades were recorded for 10 minutes, and an average of PSR for all saccades recorded was taken. | Average PSR values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill. | |
Primary | Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye. | For each saccade made by the subject, we calculated the difference (in sec) between the onset (based on a velocity threshold) of the movement in the adducting eye (the eye moving towards the nose) and the onset of the movement in the abducting eye (the eye moving away from the nose). Subjects' horizontal saccades were recorded for 10 minutes, and an average of PTD for all saccades recorded was taken. | Average PTD values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill. | |
Secondary | Reading Acuity (RA) | MNREAD acuity charts for reading acuity (RA) | Average RA values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill. | |
Secondary | Maximum Reading Speed (MRS) | MNREAD acuity charts for reading speed (maximum reading speed, MRS) | Average MRS values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill. | |
Secondary | Gait Assessment | 25-foot Walk Test (FWT) | Measures were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill. | |
Secondary | National Eye Institute (NEI) Visual Function Questionnaire 25 (VFQ-25) | We used a validated questionnaire to assess visual disability, the National Eye Institute (NEI) Visual Function Questionnaire 25. Min value 0; Max value 100; Higher scores mean a better outcome. | VFQ25 was administered on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks). | |
Secondary | 10-Item Neuro-Ophthalmic Supplement (NOS) | We used a validated questionnaire to assess visual disability, the 10-Item Neuro-Ophthalmic Supplement. Min value 0; Max value 100; Higher scores mean a better outcome. | 10-Item NOS was administered on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks). |
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