NCT01751854

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2012

Enrollment Period

7.1 years

First QC Date

December 14, 2012

Last Update Submit

December 26, 2016

Conditions

Patients With Chronic Stroke

Keywords

pharmacologyrehabilitationlocomotion

Outcome Measures

Primary Outcomes (1)

  • Peak treadmill speed

    4 weeks

Secondary Outcomes (1)

  • overground walking speed

    4 weeks

Other Outcomes (2)

  • gait kinematics

    4 weeks

  • EMG activity

    4 weeks

Study Arms (2)

SSRI

EXPERIMENTAL

SSRI alone or with training

Drug: SSRI

Placebo

PLACEBO COMPARATOR

Placebo alone or with training

Drug: Placebo

Interventions

SSRIDRUG

SSRI alone or with training

Also known as: escitalopram
SSRI
PlaceboDRUG

Placebo alone or with training

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Gourab K, Schmit BD, Hornby TG. Increased Lower Limb Spasticity but Not Strength or Function Following a Single-Dose Serotonin Reuptake Inhibitor in Chronic Stroke. Arch Phys Med Rehabil. 2015 Dec;96(12):2112-9. doi: 10.1016/j.apmr.2015.08.431. Epub 2015 Sep 14.

    PMID: 26376447DERIVED

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Thomas G Hornby

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 18, 2012

Study Start

December 1, 2004

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 28, 2016

Record last verified: 2012-12

Locations

US(1)