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Enhanced Motor Recovery Using Serotonergic Agents in Stroke

This study has been completed.
Information provided by (Responsible Party):
T. George Hornby, Rehabilitation Institute of Chicago Identifier:
First received: December 14, 2012
Last updated: December 26, 2016
Last verified: December 2012

The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neuron lesion, in particular spasticity, or enhanced, velocity-dependent stretch reflex responses to imposed stretch. While pharmacological management of spasticity certainly suppresses clinical and quantitative measures of hypertonia, there is little improvement in functional performance. In contrast, preliminary data on the administration of 5HT agents following neurological injury indicates an increase in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to maximize function following stroke despite potential, short-term increases in spastic motor activity may improve therapeutic intervention strategies. The general objective of this study is therefore to:

  1. quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis,
  2. identify the changes in impairments and functional recovery of walking ability during BWSTT with the presence or absence of SSRIs.

Condition Intervention Phase
Patients With Chronic Stroke
Drug: SSRI
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Motor Recovery Using Serotonergic Agents in Stroke

Resource links provided by NLM:

Further study details as provided by T. George Hornby, Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Peak treadmill speed [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • overground walking speed [ Time Frame: 4 weeks ]

Other Outcome Measures:
  • gait kinematics [ Time Frame: 4 weeks ]
  • EMG activity [ Time Frame: 4 weeks ]

Enrollment: 30
Study Start Date: December 2004
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI
SSRI alone or with training
Drug: SSRI
SSRI alone or with training
Other Name: escitalopram
Placebo Comparator: Placebo
Placebo alone or with training
Drug: Placebo
Placebo alone or with training

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • unilateral supratentorial stroke
  • MMSE > 22
  • > 6 months stroke duration
  • < 0.9 m/s gait speed overground

Exclusion Criteria:

  • lower extremity contracture
  • osteoporosis
  • Cardiovascular/metabolic/respiratory instability
  • previous central/peripheral nerve injury
  • concurrent medications interacting with SSRIs
  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 identifier: NCT01751854

United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Principal Investigator: Thomas G Hornby Rehabilitation Institute of Chicago
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: T. George Hornby, Research Assistant Professor, Rehabilitation Institute of Chicago Identifier: NCT01751854     History of Changes
Other Study ID Numbers: STU00014257
1250--018 ( Other Grant/Funding Number: NIDRR/FIP - H133G060124 )
Study First Received: December 14, 2012
Last Updated: December 26, 2016

Keywords provided by T. George Hornby, Rehabilitation Institute of Chicago:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017