NMDA Receptors in Motor Learning in Humans
Condition: Stroke
Intervention: D-cycloserine; Placebo; HandMentor Pro
Intervention description: D-cycloserine 100mg PO twice weekly (Monday and Wednesday) for three weeks; Placebo pill PO twice weekly (Monday and Wednesday) for three weeks; 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).
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between the ages of 18 and 95 years

          -  of either sex

          -  of diverse ethnic background

          -  have experienced a single unilateral hemispheric or brainstem stroke 3 or more months
             prior

          -  if have experienced more than one stroke, will be accepted only if all strokes are on
             the same side of the brain, there is no history of a clinical ischemic or hemorrhagic
             event affecting the other hemisphere, and there is no CT or MRI evidence of more than
             one a lacune or minor ischemic demyelination affecting the other hemisphere.

          -  active motions of the wrist and hand: 10 of wrist extension from a relaxed flexed
             position; 10 of extension of any two digits at any joint, and 10 of thumb extension at
             either joint. All active motions must be repeated 3 times within one minute.

          -  passive range of motion: 90 of flexion and abduction and 45 external and internal
             rotation at the shoulder; 45 elbow supination and pronation; elbow extension limited
             by no more than 30; wrist extension to at least neutral; and digit extension limited
             by no more than 30.

          -  participants will not be required to exhibit any active shoulder or elbow motion

          -  ability to sit independently for at least 2 minutes

          -  Mini Mental Status Examination score greater than 24

          -  Motor Activity Log score less than 3

          -  Prospective participants who qualify but who have profound postural instability will
             undergo the intervention while walking with contact guarding or, when feasible, using
             their leg and more involved arm to propel a wheelchair.

          -  must have a score below 16 on the Center for Epidemiologic Studies Depression Scale

          -  must receive a score greater than 25 on the Folstein Mini Mental State Exam.

        Exclusion Criteria:

          -  any history of more than minor head trauma, subarachnoid hemorrhage, dementia or any
             other neurodegenerative disease, multiple sclerosis, HIV infection, drug or alcohol
             abuse, serious medical illness, schizophrenia, major refractory depression

          -  insufficient cardiopulmonary function to participate in low-intensity sustained upper
             extremity exercise

          -  severe visual impairment

          -  pregnancy

          -  breast feeding

          -  participation in intensive physical therapy within the prior 12 months

          -  inability to understand the potential risks and benefits of the study, personally
             provide informed consent, and understand and cooperate with treatment

          -  participating in other upper extremity rehabilitation, clinical or experimental,
             during the course of this trial.

          -  a score of less than 24 on the Folstein Mini-Mental State Exam

          -  a score of less than10 on the Boston Naming Test

          -  a first stroke less than 3 months or more than 48 months prior to the initiation of
             therapeutic intervention

          -  less than 18 years old

          -  clinical judgment of excessive frailty or lack of stamina

          -  serious uncontrolled medical conditions

          -  excessive pain in any joint of the more affected extremity that could limit ability to
             cooperate with the intervention

          -  passive range of motion less than 45 degrees for: abduction, flexion or external
             rotation at shoulder, or pronation of forearm

          -  greater than 30 degrees flexion contracture at any finger joint

          -  unable to stand independently for 2 min., transfer independently to and from the
             toilet or perform sit-to-stand

          -  current participation in other pharmacological or physical intervention studies, or
             have received injections of anti-spasticity drugs into upper extremity musculature
             within the past 3 months, or wish to have drugs injected in the foreseeable future

          -  receiving any anti-spasticity drugs orally at the time of expected participation

          -  received phenol injections less than 12 months prior to receiving therapy

          -  contemplating a move from proximity to the treatment site in less than 6 months from
             the randomization date.