This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo.
Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks potassium channels on demyelinated neurons, allows normal electrical conduction. Dalfampridine has recently been found to be associated with improvements in visual function, strength, ambulation, fatigue, and endurance in individuals with MS. Although this medication has a widespread effect, its influence on upper extremity function has never been investigated in a double blind randomized case control study. Following the fact that during the disease course, approximately 3 out of 4 multiple sclerosis patients encounter upper limb dysfunction the primary objective of this study will be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity function in patients with MS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
Multiple Sclerosis Center
Tel Litwinsky, Ramat-gan, Israel
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Time frame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Time frame: Changes in the Nine-Hole Peg Test from Baseline to end of first week
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Time frame: Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Time frame: Changes in the Box and Block Test from Baseline to end of Second week
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Time frame: Changes in the Box and Block Test from Baseline to end of first week
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Time frame: Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
Isometric grip force and motor fatigue
Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd., USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
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Time frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
Isometric grip force and motor fatigue
Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
Time frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
Isometric grip force and motor fatigue
Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
Time frame: Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Time frame: Changes in the Sensory evaluation Test from Baseline to end of Second week
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Time frame: Changes in the Sensory evaluation Test from Baseline to end of first week
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Time frame: Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
Time frame: Changes in the DASH Test from Baseline to end of Second week
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
Time frame: Changes in the DASH Test from Baseline to end of first week
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
Time frame: Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase