NMDA Receptors in Motor Learning in Humans

Completed · Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT02082912

Run by

Emory University

People needed

14

Starts

2010-06-01

Expected to finish

2012-04-01

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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