We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhanced Motor Recovery Using Serotonergic Agents in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01751854
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Patients With Chronic Stroke Drug: SSRI Drug: Placebo Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Motor Recovery Using Serotonergic Agents in Stroke
Study Start Date : December 2004
Primary Completion Date : January 2012
Study Completion Date : January 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Other Outcome Measures:
  1. gait kinematics [ Time Frame: 4 weeks ]
  2. EMG activity [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751854


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: T. George Hornby, Research Assistant Professor, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01751854     History of Changes
Other Study ID Numbers: STU00014257
1250--018 ( Other Grant/Funding Number: NIDRR/FIP - H133G060124 )
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2012

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

Additional relevant MeSH terms:
Stroke
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