Treating Intention In Aphasia: Neuroplastic Substrates

Status Completed

Clinical Trial 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.

Clinical Trial Description

A new treatment manipulating intention substrates for language production in "nonfluent" aphasia patients was developed. The intention component involves initiating word-finding trials with a complex left-hand movement. The study addresses (1) whether or not the intention manipulation (complex left-hand movement) makes a unique contribution to treatment outcome and (2) whether or not the intention manipulation helps to shift word production mechanisms from the left to the right frontal lobe. All study participants take part in functional magnetic resonance imaging (fMRI) scans of word-finding before and after treatment and at 3-month follow-up to measure changes in lateralization of frontal lobe activity during word finding. Only patients with a substantial degree of left frontal activity on the pre-treatment fMRI scan can participate. There are three specific aims: (1) to determine if repetitive initiation of word production with a complex left-hand movement leads to increased right-hemisphere lateralization of frontal activity and if these changes can be attributed to the intention component of treatment, (2) to determine whether activity in posterior perisylvian cortices that is entrained to right frontal activity shows a greater increase in right-hemisphere lateralization from pre- to post-treatment fMRI when the intention component is included in treatment, and (3) to determine whether onset of hemodynamic responses (HDRs) in right motor/premotor cortex becomes more closely associated with the temporal onset of participants' spoken responses across treatment when the intention component is included in treatment. If successful, the treatment can provide a new treatment vehicle for increasing language function in patients with "nonfluent" aphasia. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00567242
Study type	Interventional
Source	University of Florida
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	March 2007
Completion date	September 2009

View Details

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	`NCT02557737` - Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities	Phase 3
Recruiting	`NCT01769326` - Influence of Timing on Motor Learning	N/A
Terminated	`NCT01705353` - The Role of HMGB-1 in Chronic Stroke	N/A
Completed	`NCT01182818` - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease	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	`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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.