Enhanced Motor Recovery Using Serotonergic Agents in Stroke
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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:
- quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis,
- 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 |
- Peak treadmill speed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- overground walking speed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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 |
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| United States, Illinois | |
| Rehabilitation Institute of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| 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 Citalopram Serotonin Agents |
Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013