NCT00713050

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

August 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
3.5 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
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

4.4 years

First QC Date

July 9, 2008

Last Update Submit

June 10, 2013

Conditions

Ischemic Stroke

Keywords

strokeaphasiaimitationmirror neuron

Outcome Measures

Primary Outcomes (1)

  • Changes in scores on Western Aphasia Battery

    Four months

Study Arms (2)

Experimental

EXPERIMENTAL

Computer-based Aphasia therapy

Behavioral: Imitate Therapy

Control

ACTIVE COMPARATOR

Control Arm - Healthy subjects.

Behavioral: Imitate Therapy

Interventions

Imitate TherapyBEHAVIORAL

Imitation-based computer therapy

Also known as: Imitate
ControlExperimental

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Solodkin/Small Brain Circuits Laboratory

Irvine, California, 92697, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

  • 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.

    PMID: 27053642DERIVED

MeSH Terms

Conditions

Ischemic StrokeStrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Small, M.D., Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(2)