Status:
COMPLETED
Methylphenidate to Improve Balance and Walking in MS
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Portland VA Medical Center
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis tachycardia syndrome and...
Detailed Description
The proposed pilot study will examine the effects of methylphenidate on imbalance and walking in 24 subjects with MS and imbalance. The subjects will be randomly assigned to receive either an escalati...
Eligibility Criteria
Inclusion
- Age 20-65
- Able to walk at least 100m without an aide or with unilateral assistance
- Poor static balance, specifically prolonged APR latencies (≥ 1 standard deviation (SD) \> mean for healthy people in this age range), OR
- Reduced balance-related activity (ABC scores ≤ 85%)
- Walking difficulties, specifically T25FW \> 6 seconds, OR reduced self perceived walking (MSWS-12 scores ≥ 50/60)
Exclusion
- Currently taking methylphenidate, modafinil, or armodafinil.(any within the last 2 weeks)
- Cause(s) of imbalance other than MS
- Systolic pressure consistently greater than 150 mm Hg or diastolic pressure consistently greater than 90 mm Hg
- Contraindications to methylphenidate (Anxiety, tension, agitation, thyrotoxicosis, tachyarrhythmias, severe angina pectoris or glaucoma, hypersensitivity to methylphenidate, motor tics or a family history or diagnosis of Tourette's syndrome, seizures, severe or poorly controlled hypertension, treatment with monoamine oxidase inhibitors currently or within the last 14 days, current use of guanethidine, pressors, coumarin anticoagulants, anticonvulsants, phenylbutazone, or tricyclic antidepressants, history of drug abuse or alcoholism)
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01896700
Start Date
July 1 2013
End Date
April 1 2016
Last Update
April 5 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Portland VA Medical Center
Portland, Oregon, United States, 97239