NMDA Receptors in Motor Learning in Humans
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. This study is about arm and hand recovery 3 months post-stroke. 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.
Participants will be randomly assigned to one of two groups. No matter what group patients are assigned they will receive 3 weeks of therapy. However, one group will receive a drug that may improve learning new motor skills while the other group will receive a sugar pill. The robotic therapy will last 2 hours per day for 2 consecutive weeks. The hand robot helps participants move the wrist up and down with activities that require varying levels of wrist control and are aimed at increasing the active range of motion of the wrist. This type of training is thought to provide patients with challenging, intensive and meaningful practice using the arm that was most affected by their stroke. The overall intent of this type of training is to improve participants' skill and confidence in using the arm that was most affected.
The drug (called D-cycloserine) is approved for use in people by the FDA. It may enhance certain features of motor skill learning, by improving memory while doing motor skills. The memory effect can be coupled with robotic-assisted physical therapy to improve the function of impaired limbs to a greater extent and at a faster rate than may occur without the drug.
It has been shown that an alteration or change in a specific gene has been associated in methods related to movement recovery after stroke. These same genes may also be important to recovery from stroke in humans.
This study asks how these genes and patients' recovery following therapy may have an effect on outcome after stroke. Genetic testing (done by swabbing the inside of the mouth with a q-tip) will be done at the initial visit to test for the presence/absence of these hereditary markers in the saliva. A change in behavioral measures (as seen by the two testing sessions) may show a relationship between the presences of selected forms of genetic variation.
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
- Change in Hand Grip Strength [ Time Frame: Baseline and at end of 3 weeks of treatment ] [ Designated as safety issue: No ]
- Change in Stroke Impact Scale score [ Time Frame: Baseline and at end of 3 weeks of treatment ] [ Designated as safety issue: No ]
- Change in depressive symptoms [ Time Frame: Baseline and at end of 3 weeks of treatment ] [ Designated as safety issue: No ]
- Change in memory and information processing speed [ Time Frame: Baseline and at end of 3 weeks of treatment ] [ Designated as safety issue: No ]
- Change in functional motor task performance [ Time Frame: Baseline and at end of 3 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: D-cycloserine
D-cycloserine, 100mg, 2x per week
Placebo Comparator: Placebo
Placebo pill, 2x per week
Please refer to this study by its ClinicalTrials.gov identifier: NCT02082912
|United States, Georgia|
|Atlanta, Georgia, United States|