NMDA Receptors in Motor Learning in Humans

NCT02082912 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00035176UL1TR000454
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Grip Strength of Affected Hand

  Hand-grip strength was assessed using the whole hand and was 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. An increase in values means that grip strength is improving.

  Baseline, Day 30

Secondary Outcomes (4)

• Percentage of Stroke Impact Scale (SIS) Categories Meeting Change Criteria

  Baseline, Day 30

• Center for Epidemiologic Studies Depression (CES-D) Scale Score

  Baseline, Day 30

• Display Enhanced Testing for Concussions and Mild Traumatic Brain Injury (mTBI) (DETECT) System Score

  Baseline, Day 30

• Number of Blocks Moved During the Box and Block Test (BBT) of Affected Arm

  Baseline, Day 30

Study Arms (2)

D-cycloserine

EXPERIMENTAL

Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy

Drug: D-cycloserine; Device: HandMentor Pro

Placebo

ACTIVE COMPARATOR

Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy

Other: Placebo; Device: HandMentor Pro

Interventions

D-cycloserine DRUG

D-cycloserine 100mg PO twice weekly (Monday and Wednesday) for three weeks

Also known as: Seromycin

D-cycloserine

Placebo OTHER

Placebo pill PO twice weekly (Monday and Wednesday) for three weeks

Placebo

HandMentor Pro DEVICE

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).

D-cycloserine; Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Butler AJ, Kallos J, Housley SN, LaPlaca MC, Traynelis SF, Wolf SL. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke. Rehabil Res Pract. 2015;2015:534239. doi: 10.1155/2015/534239. Epub 2015 Oct 26.

  PMID: 26587287 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Andrew John Butler
• Organization: Emory University

ajbutle@emory.edu

404-413-1415

Study Officials

• Andrew Bulter, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 10, 2014
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 7, 2018
• Results First Posted: April 22, 2015

Record last verified: 2018-10

Locations

US (1)