NMDA Receptors in Motor Learning in Humans

Completed

Phase 2 Results

Trial Description

The purpose of this study is to focus on enhancing upper limb recovery in patients post-stroke by using robotic-assisted therapy in combination with a drug to improve learning new motor skills.

Detailed Description

Disability after a stroke is common, leaving 65% of patients unable to use their affected hand in daily activities after 6 months. Frequently, these limitations can cause a decreased quality of life. Therefore, the purpose of this study is to understand the important factors in rehabilitation therapy that help improve arm function after stroke. This information may help to ultimately reduce disability and improve quality of life in patients with stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo pill PO twice weekly (Monday and Wednesday) for three weeks
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo pill, 2x per week
  • D-cycloserine Drug
    Other Names: Seromycin
    Intervention Desc: D-cycloserine 100mg PO twice weekly (Monday and Wednesday) for three weeks
    ARM 1: Kind: Experimental
    Label: D-cycloserine
    Description: D-cycloserine, 100mg, 2x per week
  • HandMentor Pro Device
    Intervention Desc: The HandMentor Pro (Kinetic Muscles Inc.) is a robotic device that has recording electrodes. The device gives feedback during various activities requiring varying levels of wrist control. The main goal of the hand robot is to improve active range of motion about the wrist and fingers and wrist control. The robotic therapy will be done over 3 consecutive weeks for 2 hours each session (days 1, 3, 5, 8, 10, 12, 15, 17 and 19, for 18 hours total).
    ARM 1: Kind: Experimental
    Label: D-cycloserine
    Description: Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Hand Grip Strength Baseline and at end of 3 weeks of treatment No
Primary Change in Stroke Impact Scale score Baseline and at end of 3 weeks of treatment No
Primary Change in depressive symptoms Baseline and at end of 3 weeks of treatment No
Primary Change in memory and information processing speed Baseline and at end of 3 weeks of treatment No
Primary Change in functional motor task performance Baseline and at end of 3 weeks of treatment No
Primary Mean Change in Grip Strength of Affected Hand Baseline, 3 weeks (end of treatment) No

Sponsors