Trial record 1 of 9 for:    NMDA receptors AND stroke
Previous Study | Return to List | Next Study

NMDA Receptors in Motor Learning in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrew Butler, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT02082912
First received: March 5, 2014
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: D-cycloserine
Other: Placebo
Device: HandMentor Pro
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:
  • Mean Change in Grip Strength of Affected Hand [ Time Frame: Baseline, 3 weeks (end of treatment) ] [ Designated as safety issue: No ]
    Hand-grip strength was assessed using the whole hand and defined as the average of 3 trials using a calibrated Jamar dynamometer (Jamar Dynamometer, Asimow Engineering Co., Santa Monica, CA), with the elbow flexed to 90º and the forearm in a neutral position. This is the standardized method for measuring hand-grip strength with a Jamar dynamometer recommended by the American Society of Hand Therapists. Change was calculated by subtracting baseline from outcome at week 3.


Secondary Outcome Measures:
  • 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
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-cycloserine
Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
Drug: D-cycloserine
D-cycloserine 100mg PO twice weekly (Monday and Wednesday) for three weeks
Other Name: Seromycin
Device: HandMentor Pro
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).
Active Comparator: Placebo
Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
Other: Placebo
Placebo pill PO twice weekly (Monday and Wednesday) for three weeks
Device: HandMentor Pro
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).

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.

  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, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Andrew Bulter, PhD 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
Results First Received: April 9, 2015
Last Updated: April 9, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015