Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 441 for:    Methylphenidate

Methylphenidate to Improve Balance and Walking in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896700
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 11, 2013
Results First Submitted Date  ICMJE October 10, 2017
Results First Posted Date  ICMJE April 5, 2018
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks [ Time Frame: 6 weeks ]
The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
Timed Up and Go time (TUG time) [ Time Frame: From enrollment to study completion ]
The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at each dose. Changes in TUG times will be calculated by comparing the TUG time at each time point (i.e. dose) after intervention (T+2weeks, T+4weeks and T+6weeks) with the baseline TUG time. Mean changes at each time point will be compared for active and placebo treated subjects using t-tests.
Change History Complete list of historical versions of study NCT01896700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks [ Time Frame: 6 weeks ]
    Mean changes in APR latency at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.
  • Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks [ Time Frame: 6 weeks ]
    Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.
  • Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks [ Time Frame: 6 weeks ]
    Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-21 points, with higher numbers indicating poorer sleep quality.
  • Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks [ Time Frame: 6 weeks ]
    Mean changes in the score attached on the Modified Fatigue Index Scale at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-84 points, with higher scores indicating greater fatigue.
  • Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks [ Time Frame: 6 weeks ]
    The most common rotary chair testing is a battery of subtests, each at a specific rate (Hz) of chair rotation from side to side. The participant is secured in the chair in total darkness while the eyes are monitored by infrared cameras. We completed tests from 0.04 to 0.64 Hz to assess the vestibular system across a range of head movements. The chair and participant's head move together while the cameras track the velocity of the eyes; eye velocity reveals how the vestibular system responds to head velocity. VOR gain is the ratio of average chair (i.e. head) velocity to average eye velocity, and is represented on a unitless scale from 0 to 1. VOR gain close to 1 indicates that eye velocity is nearly equal and opposite to head velocity. While there are normative ranges for VOR gain, we are most interested in is change in mean gain (6-week tests minus baseline tests) for the active and placebo groups.
  • Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks [ Time Frame: 6 weeks ]
    Mean changes in VOR asymmetry, which is a measure of the strength of the eye responses in one direction compared with the other as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.
  • Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks [ Time Frame: 6 weeks ]
    Mean changes in VOR phase, which is a measure of the timing (in degrees) of the eye movements relative to the chair movement, as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
  • Automatic Postural Response (APR) Latency (in sec) [ Time Frame: From enrollment to study completion ]
    Mean changes in APR latency at each time point will be compared for active and placebo treated subjects using t-tests.
  • Timed 25 Foot Walk (T25FW in secs) [ Time Frame: From enrollment to study completion ]
    Mean changes in Timed 25 Foot Walk (T25FW) at each time point will be compared for active and placebo treated subjects using t-tests.
  • Pittsburgh Sleep Quality Assessment Questionnaire score [ Time Frame: From enrollment to study completion ]
    Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at each time point will be compared for active and placebo treated subjects using t-tests.
  • Modified Fatigue Index Scale score [ Time Frame: From enrollment to study completion ]
    Mean changes in the score attached on the Modified Fatigue Index Scale at each time point will be compared for active and placebo treated subjects using t-tests.
  • Vestibular-Ocular Reflex time (in secs) [ Time Frame: From enrollment to study completion ]
    Mean changes in saccade latency and peak velocity at each time point will be compared for active and placebo treated subjects using t-tests.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylphenidate to Improve Balance and Walking in MS
Official Title  ICMJE Methylphenidate to Improve Balance and Walking in MS
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 narcolepsy. It is also often prescribed off label to people with MS to improve fatigue. It is proposed that methylphenidate may also improve imbalance and walking deficits in MS by improving concentration and central integration, one of the primary mechanisms thought to underlie imbalance and walking deficits in MS.
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 escalating does of methylphenidate, 20mg, 40mg or 60mg, divided into two doses each day, or matched placebo for 2 weeks at each dose. If a subject does not tolerate dose escalation they will be instructed to discontinue use of the drug. The maximum safely tolerated dose for each subject will be noted. Changes from baseline in subject's walking speed, balance, vestibular function, cognitive function, and fatigue will be assessed at each dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Methylphenidate
    Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each
    Other Name: Ritalin
  • Drug: Placebo
    Escalating matched dose of placebo
Study Arms  ICMJE
  • Experimental: Methylphenidate

    Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.

    Other name: Ritalin

    Intervention: Drug: Methylphenidate
  • Placebo Comparator: Placebo
    Placebo pill, bid for 6 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896700
Other Study ID Numbers  ICMJE 3055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle Cameron, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Portland VA Medical Center
Investigators  ICMJE
Principal Investigator: Michelle Cameron, PT, MD Portland VA Medical Center
PRS Account Oregon Health and Science University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP