fMRI of Language Recovery Following Stroke in Adults

NCT00843427 | Completed

• 2 other identifiers: R01NS0482811R01NS048281-01A2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.

Conditions

Aphasia; Stroke

Keywords

aphasia; stroke; functional magnetic resonance imaging; fMRI; language recovery after stroke; constraint-induced aphasia therapy; CIAT

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure is aphasia improvement.

  The Token Test was used only for primary screening and study qualification. All participants received NAT which included: (1) the Boston Naming Test (BNT) (Kaplan, Goodglass et al. 1983), (2) the Controlled Oral Word Association Test (Lezak 1995), (3) the Semantic Fluency Test (SFT) (Kozora and Cullum 1995, Lezak 1995), (4) the Complex Ideation subtest from the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass and Kaplan 1972), (5) the Peabody Picture Vocabulary Test III (PPVT III) (Dunn and Dunn 1997), and (6) the Mini-Communicative Activities Log (Mini-CAL) which is a subjective measure of communicative abilities (Pulvermuller, Neininger et al. 2001, Szaflarski, Ball et al. 2008).

  1 week and 3 months after intervention

Study Arms (2)

Aphasia - CIAT

EXPERIMENTAL

Patients with aphasia \>1 year after left MCA stroke who will be randomized to receive CIAT

Behavioral: CIAT

Aphasia - observation

NO INTERVENTION

Patients with aphasia \>1 year after left MCA stroke who will be randomized to no intervention (observation)

Interventions

CIAT BEHAVIORAL

Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.

Also known as: CILT

Aphasia - CIAT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
• Moderate aphasia (Token Test score between 40th and 90th percentile)
• Written informed consent by the patient or the next of kin

You may not qualify if:

• Underlying degenerative or metabolic disorder or supervening medical illness
• Severe depression or other psychiatric disorder
• Pregnancy
• Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (23)

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• Meinzer M, Elbert T, Wienbruch C, Djundja D, Barthel G, Rockstroh B. Intensive language training enhances brain plasticity in chronic aphasia. BMC Biol. 2004 Aug 25;2:20. doi: 10.1186/1741-7007-2-20.

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• Saur D, Lange R, Baumgaertner A, Schraknepper V, Willmes K, Rijntjes M, Weiller C. Dynamics of language reorganization after stroke. Brain. 2006 Jun;129(Pt 6):1371-84. doi: 10.1093/brain/awl090. Epub 2006 Apr 25.

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• Szaflarski JP, Ball A, Grether S, Al-Fwaress F, Griffith NM, Neils-Strunjas J, Newmeyer A, Reichhardt R. Constraint-induced aphasia therapy stimulates language recovery in patients with chronic aphasia after ischemic stroke. Med Sci Monit. 2008 May;14(5):CR243-250.

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• Szaflarski JP, Binder JR, Possing ET, McKiernan KA, Ward BD, Hammeke TA. Language lateralization in left-handed and ambidextrous people: fMRI data. Neurology. 2002 Jul 23;59(2):238-44. doi: 10.1212/wnl.59.2.238.

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• Tillema JM, Byars AW, Jacola LM, Schapiro MB, Schmithorst VJ, Szaflarski JP, Holland SK. Cortical reorganization of language functioning following perinatal left MCA stroke. Brain Lang. 2008 May;105(2):99-111. doi: 10.1016/j.bandl.2007.07.127. Epub 2007 Oct 1.

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MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jerzy P. Szaflarski, MD, PhD

  University of Alabama at Birmingham, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)