Speech and Language Therapy After Stroke | NCT00713050

Studies
Speech and Language Therapy After Stroke

NCT00713050

Sponsor

University of Chicago

Status

Terminated

Last Update Posted

Jun 11, 2013Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Ischemic Stroke

Interventions

Imitate Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01DC007488-05	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Protocol expired; PI retired

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jul 9, 2008

First Submission Date that Met QC Criteria

Jul 9, 2008

First Posted Date

Jul 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2013

Last Update Posted Date

Jun 11, 2013Estimated

Name	Class
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH
Shirley Ryan AbilityLab	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.

Detailed Description

Detailed information will follow in the next progress report.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Computer-based Aphasia therapy	Behavioral: Imitate Therapy
Control	Active Comparator	Control Arm - Healthy subjects.	Behavioral: Imitate Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imitate Therapy	Behavioral	Imitation-based computer therapy	Control Experimental

Measure	Description	Time Frame
Changes in scores on Western Aphasia Battery		Four months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)
Aphasia
Visual attention and language comprehension sufficient to perform imitation fMRI tasks
Right handed (prior to stroke)

Exclusion Criteria:

Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Small, M.D., Ph.D.	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Solodkin/Small Brain Circuits Laboratory		Irvine	California	92697	United States
University of California Irvine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27053642	Derived	Duncan ES, Schmah T, Small SL. Performance Variability as a Predictor of Response to Aphasia Treatment. Neurorehabil Neural Repair. 2016 Oct;30(9):876-82. doi: 10.1177/1545968316642522. Epub 2016 Apr 6.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke
D001037	Aphasia