Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00076479
Other study ID # 040100
Secondary ID 04-N-0100
Status Completed
Phase N/A
First received January 22, 2004
Last updated March 3, 2008
Start date January 2004
Est. completion date January 2006

Study information

Verified date January 2006
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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 subject's 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility INCLUSION CRITERIA:

We will include patients with thromboembolic non-hemorrhagic hemispheric lesions and with hemorrhagic hemispheric lesions (as documented by CT or MRI) at least 12 months after the stroke.

We will choose subjects with chronic stable aphasia, that initially presented with severe aphasia and have partially recovered.

Assessment of the initial functional state will be taken either from patient report or medical records. All of the aphasic patients are already known to the investigators from the NIDCD.

EXCLUSION CRITERIA - HEALTHY CONTROLS:

Unable to perform the task (naming of everyday objects in less than 10 s).

History of alcohol or drug abuse or psychiatric illness like depression.

Epilepsy.

Are less than 18 years of age.

Pregnant or breast feeding a child.

EXCLUSION CRITERIA - PATIENTS:

Unable to perform the task (naming of everyday objects in less than 10 s).

History of alcohol or drug abuse or psychiatric illness like depression.

Epilepsy.

Are less than 18 years of age.

Pregnant or breast feeding a child.

Patients with cerebellar or brainstem lesions.

Patients or subjects with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease).

Patients or subjects with increased intracranial pressure as evaluated by clinical means.

Individuals receiving drugs acting primarily on the central nervous system.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Abrahams S, Goldstein LH, Simmons A, Brammer MJ, Williams SC, Giampietro VP, Andrew CM, Leigh PN. Functional magnetic resonance imaging of verbal fluency and confrontation naming using compressed image acquisition to permit overt responses. Hum Brain Mapp. 2003 Sep;20(1):29-40. — View Citation

Amassian VE, Maccabee PJ, Cracco RQ, Cracco JB, Somasundaram M, Rothwell JC, Eberle L, Henry K, Rudell AP. The polarity of the induced electric field influences magnetic coil inhibition of human visual cortex: implications for the site of excitation. Electroencephalogr Clin Neurophysiol. 1994 Feb;93(1):21-6. — View Citation

Basso A, Gardelli M, Grassi MP, Mariotti M. The role of the right hemisphere in recovery from aphasia. Two case studies. Cortex. 1989 Dec;25(4):555-66. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT05477238 - Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls N/A
Completed NCT00046293 - ReoPro and Retavase to Treat Acute Stroke Phase 2
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT01116544 - Treatment of Chronic Stroke With AMES + EMG Biofeedback N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Active, not recruiting NCT02563886 - Electrically Assisted Movement Therapy N/A
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT02141932 - Pocket-size Cardiovascular Ultrasound in Stroke N/A
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Recruiting NCT01769326 - Influence of Timing on Motor Learning N/A
Recruiting NCT02557737 - Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities Phase 3
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Completed NCT01656876 - The Effects of Mirror Therapy on Upper Extremity in Stroke Patients N/A
Completed NCT01423201 - Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00542256 - tDCS and Physical Therapy in Stroke N/A
Withdrawn NCT00573092 - Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs N/A
Completed NCT00377689 - Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke Phase 2
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT00149435 - Cardiovascular Health Study (CHS) Events Follow-up Study