Intention Treatment for Anomia

NCT04267198 | Completed

• 1 other identifier: N3093-R
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Every year approximately 15,000 Veterans are hospitalized for stroke, and up to 40% of those Veterans will experience stroke-related language impairment (i.e., aphasia). Stroke-induced aphasia results in increased healthcare costs and decreased quality of life. As the population of Veterans continues to age, there will be an increasing number for Veterans living with the aphasia and its consequences. Those Veterans deserve to receive aphasia treatment designed to facilitate the best possible outcomes. In the proposed study, the investigators will investigate optimal treatment intensity and predictors of treatment response for a novel word retrieval treatment. The knowledge the investigators gain will have direct implications for the selecting the right treatment approach for the right Veteran.

Conditions

Aphasia; Stroke

Keywords

aphasia; language; rehabilitation; speech-language pathology

Outcome Measures

Primary Outcomes (11)

• Number of correctly named pictures

  Change in the ability to correctly name 10 trained and 10 untrained pictures will be measured at 4 time points

  Through study completion, an average of 6 months; Change from baseline to 3 weeks (post massed-INT) or 12 weeks (post distributed-INT), change at 3 months post-treatment, change at 6 months post-treatment

• Number of correctly generated category members

  Change in the ability to correctly name 5 trained and 5 untrained category members will be measured at 4 time points

  Through study study completion, an average of 6 months; Change from baseline to 3 weeks (post m-INT) or 12 weeks (post d-INT), change at 3 months post-treatment, change at 6 months post-treatment

• Western Aphasia Battery

  This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome

  Baseline

• Boston Naming Test

  This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome

  Baseline

• Test of Everyday Attention

  This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  Baseline

• Brief Visuospatial Memory Test-Revised

  This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  Baseline

• Hopkins Verbal Learning Test-Revised

  This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  Baseline

• Digit Span Backwards

  This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  Baseline

• Delis-Kaplan Executive Function System (D-KEFS) Sorting

  This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  Baseline

• Structural MRI scan

  Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.

  Baseline

• Functional MRI scan

  Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.

  Baseline

Secondary Outcomes (1)

• Delis-Kaplan Executive Function System (D-KEFS) Trails

  Baseline

Study Arms (2)

Massed Intention Treatment (massed-INT)

ACTIVE COMPARATOR

Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks.

Behavioral: Intention Treatment for Anomia

Distributed Intention Treatment (distributed-INT)

ACTIVE COMPARATOR

Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks.

Behavioral: Intention Treatment for Anomia

Interventions

Intention Treatment for Anomia BEHAVIORAL

Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.

Distributed Intention Treatment (distributed-INT); Massed Intention Treatment (massed-INT)

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English as primary language
• \> 6 months post-onset a left-hemisphere stroke. Multiple strokes are acceptable as long as they are confined to the left hemisphere.
• Diagnosis of aphasia
• Presence of word retrieval deficits
• Adequate comprehension as judged by ability to complete two-step commands on the Western Aphasia Battery.

You may not qualify if:

• Severe apraxia of speech or dysarthria
• Clinically significant depression
• For MRI safety: implanted medical devices, metal in the body and claustrophobia.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke; Language

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; Communication; Behavior

Study Officials

• Amy D. Rodriguez, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by study staff blind to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 12, 2020
• Study Start: May 24, 2021
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)