Trial record 1 of 8 for:    NMDA receptors AND stroke
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NMDA Receptors in Motor Learning in Humans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andrew Butler, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT02082912
First received: March 5, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: D-cycloserine
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 14
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)
Arms Assigned Interventions
Active Comparator: D-cycloserine
D-cycloserine, 100mg, 2x per week
Drug: D-cycloserine
Placebo Comparator: Placebo
Placebo pill, 2x per week
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 demylination 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082912

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States
Sponsors and Collaborators
Emory University
  More Information

No publications provided

Responsible Party: Andrew Butler, PhD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02082912     History of Changes
Other Study ID Numbers: IRB00035176
Study First Received: March 5, 2014
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014