Enhanced Motor Recovery Using Serotonergic Agents in Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
T. George Hornby, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01751854
First received: December 14, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 (Sanger 2004). 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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Peak treadmill speed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overground walking speed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • gait kinematics [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • EMG activity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01751854

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

No publications provided

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
Study First Received: December 14, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rehabilitation Institute of Chicago:
pharmacology
rehabilitation
locomotion

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014