Viewing Study NCT00076479



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00076479
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2004-01-22

Brief Title: Role of the Right Brain in Recovery of Language Function in Chronic Stroke
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2006-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will examine in healthy individuals and in patients with aphasia a language disturbance that is usually caused by stroke brain disease or injury which parts of the brain are involved in naming everyday objects In most people language and speech originate in the left side of the brain When this side of the brain is damaged language function is often impaired Often however function partly recovers possibly because the right half of the brain takes over some language functions when the left half is injured

Healthy volunteers and patients with aphasia due to stroke may be eligible for this study All candidates must be 18 years of age and older Patients aphasia must have occurred as the result of a stroke that occurred more than 12 months before entering the study In addition their stroke must not have affected the brainstem or cerebellum Candidates will be screened with a medical history brief physical examination and questionnaire about handedness Participants will undergo the following tests and procedures

Session 1 Magnetic resonance scanning MRI

MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues including the brain The subject lies in a cylindrical machine for up to 60 minutes Loud thumping noises occur when the radiofrequency circuits are switched this noise can be muffled by the use of earplugs

Sessions 2 and 3 Picture naming during transcranial magnetic stimulation TMS

For transcranial magnetic stimulation a wire coil is held on the subjects scalp A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The subject hears a click and feels a pulling sensation on the skin under the coil There may also be a twitch in the muscles of the arm or leg During the TMS subjects are asked to name pictures of common everyday objects that appear on a computer screen They are asked to name them as fast and as accurately as possible Their voice is recorded to determine the accuracy of their answers and the time it takes to answer Subjects may also be asked to tense certain muscles slightly or perform other simple actions during the TMS to position the coil properly
Detailed Description: Background Aphasia a language impairment usually induced by stroke is typically the result of damage to the left hemisphere Severity of this disorder can vary across patients as well as the degree of impairment at various levels of linguistic processes However one consistent symptom of aphasia is anomia or dysnomia which is a word finding deficit Given the reliable presence of anomia picture naming is a common task used both clinically and experimentally to probe linguistic processing

Functional imaging studies have suggested that the right hemisphere may be recruited to compensate for loss of left hemispheric language regions However they could not assess the functional significance of the observed activations In a previous experiment NIDCD protocol 92-DC-0178 we have identified the areas activated in association with language function picture naming in patients with chronic stroke that have partially recovered from an initially severe aphasia and in healthy age- and gender-matched controls The preliminary outcome is increased involvement of the right hemisphere for picture naming in recovered aphasics

Objectives In the present protocol we plan to test the hypothesis that right hemispheric homologues of traditional left hemispheric anterior and posterior language areas are the neural substrate mediating recovery of language functions in patients with chronic stroke This investigation is important because it can provide novel evidence on plasticity of language functions in chronic stroke

Study Population We plan to include chronic stroke patients that suffer from aphasia and healthy age- and gender-matched controls

Design We will test if inhibitory transcranial magnetic stimulation TMS of right-hemispheric cortical areas inferior frontal gyrus - IFG superior temporal gyrus - STG middle temporal gyrus - MTG that are activated during picture naming will result in a decrease in task performance picture naming latency in chronic stroke patients in comparison to stimulation of left hemispheric areas in aphasics and right-hemispheric homologue areas in healthy controls The TMS experiment is necessary to identify a cause-effect link between right hemispheric activation and recovery of language functions after chronic stroke Stereotactic applications of TMS during the picture naming task will be implemented over six cortical sites in both groups left IFG left STG left MTG and right IFG right STG and right MTG

Outcome Measures The outcome measure will be performance on the picture naming task primary outcome measure reaction time during TMS as a function of subject group and stimulation site

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
04-N-0100 None None None