Phase 2 N=14 Randomized Single-blind Treatment

Treating Intention In Aphasia: Neuroplastic Substrates

Aphasia · Cerebrovascular Accident

Bottom Line

View on ClinicalTrials.gov: NCT00567242 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production — -0.2802; -0.1832 laterality index — p=<.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Word-finding with intention component (Behavioral); Word-finding with no intention component (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production	-0.2802; -0.1832	<.05 sig
SECONDARY Picture Naming Probe Scores (% Accuracy)	3.68; 3.92	<.05 sig
SECONDARY Category Member Generation Probe Scores (% Accuracy)	3.50; 1.94	<.05 sig

Summary

The purpose of this study is to determine if an "intentional act" improves treatment response for patients with nonfluent aphasia. The treatment involves naming pictures and saying members of categories. The "intentional act" requires initiating picture naming or category member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language production in which patients with damage to the brain's language system have trouble initiating and maintaining spoken communication. All patients participating in the study take part in functional MRI scans to determine how treatments affect brain systems.

Eligibility Criteria

Inclusion Criteria

Nonfluent aphasia caused by stroke
Moderate to severe word-finding problems
6 or more months post stroke
Right handed prior to stroke
All strokes in left hemisphere
Native English speaker
Capable of following verbal directions

Exclusion Criteria

Severe impairment of word comprehension
Brain injury or disease in addition to stroke
Drug or alcohol abuse within past 6 months
Schizophrenia or other psychiatric disorder necessitating hospitalization
History of learning disability
Claustrophobia
Cardiac pace-maker
Ferrous metal implants not attached to bone, metal fragments in body
Profound hearing loss

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00567242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.