Memantine for Enhanced Stroke Recovery

Overview

Status: Active, not recruiting
Keywords: Stroke , Memantine , Motor Recovery , Rehabilitation
IRB Number: 00068751
Specialty: Occupational Therapy, Physical Medicine and Rehabilitation, Neurology
Sub Specialties: Stroke , Stroke

Brief Summary

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke.   Target enrollment will be 10 patients per group and adaptive randomization will be used to assist with equal representation of pre-stroke selective serotonin reuptake inhibitor (SSRI) use and motor severity (Fugl-Meyer score) in each arm.  The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in each group in order to power a larger efficacy trial at the University of Utah.  An intention to treat model will be used during the study.  

Objectives:

Primary:

Hypothesis 1: Individuals treated with memantine for 12 weeks after an acute ischemic stroke will show greater improvements on the Fugl-Meyer Upper Extremity (FMUE) and Fugl-Meyer Lower Extremity (FMLE) than individuals who receive a placebo. 

Hypothesis 2: Individuals treated with memantine for 12 weeks after an acute ischemic stroke will have no greater serious adverse events than individuals who receive placebo.

Secondary:

Hypothesis 3: Individuals treated with memantine for 12 weeks after acute ischemic stroke will show greater improvements in upper extremity (UE) functioning as measure by the Grip Strength Test, Motor Activity Log, and the hand subscale of the Stroke Impact Scale than those who received placebo.

Hypothesis 4: Individuals treated with memantine for 12 weeks after acute ischemic stroke will show greater improvements in LE functioning as measured by the Ten Meter Walk Test and the mobility subscale of the Stroke Impact Scale than those who receive placebo. 

Hypothesis 5: Individuals treated with memantine for 12 weeks after acute ischemic stroke will show greater improvements in activity and participation as measured by the total Stroke Impact Scale than those who received placebo.

Principal Investigator: Alicia Bennett
Department: Neurology
Co Investigator: Kevin Brennan
Co Investigator: Tina Burton
Co Investigator: Edward DiBella
Co Investigator: Dana DeWitt
Co Investigator: Jana Wold
Co Investigator: Lorie Richards
Co Investigator: Jennifer Majersik
Co Investigator: Steven Edgley

Contact Information

Name:Alicia Bennett
Phone: 801-585-2033
Email: alicia.bennett@hsc.utah.edu

Inclusion Criteria

  1. Age 18-80 years old
  2. Randomization between 3-8 days of stroke symptom onset
  3. Arm weakness severe enough to warrant inpatient or outpatient occupational therapies
  4. Able to voluntarily move the wrist or a digit of the affected UE
  5. Living independently prior to their stroke
  6. Image-confirmed ischemic stroke (MRI or CT)
  7. Supratentorial location of stroke
  8. Fugl-Meyer Score of 55 or less
  9. Ability to swallow pills

Exclusion Criteria

  1. Hemorrhagic stroke, subarachnoid hemorrhage, or other cause of symptoms other than ischemic stroke
  2. Infratentorial location of stroke (brainstem or cerebellum)
  3. NIH Stroke Scale >20 at the time of randomization
  4. History of dementia that will interfere with rehab
  5. Pre or post-stroke use of memantine or amantadine
  6. Contraindications to taking memantine in pill form
  7. History of prior clinical stroke
  8. Documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment if not done as part of clinical care.
  9. Moribound or not expected to live 6 months
  10. Severe cognitive deficits or pre-morbid function causing inaccurate neurologic assessment or inability to complete the initial assessment
  11. Comorbid neurologic disease expected to interfere with the results. This could include diseases such as Multiple Sclerosis, neurodegenerative diseases, spinal cord disease, and CNS cancer, at the judgement of the PI.
  12. Documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
  13. Patients who are pregnant or breast feeding