Intention Treatment for Anomia

NCT ID: NCT04267198

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Difficulty retrieving words is one of the most common language complaints in individuals with stroke-induced aphasia. The negative consequences related to word retrieval impairment include increased health care costs and decreased quality of life. A variety of treatment approaches exist to improve word retrieval, and most of the treatments result in immediate improvement on trained words. However, long-term improvement and improvement on untrained words or behaviors is less common. Additionally, the investigators currently know very little about optimal treatment administration parameters, and the investigators know even less about predictors of treatment response. To make the best use of the limited clinical resources available for aphasia treatment, and to maximize outcomes for Veterans with aphasia, the investigators must: 1) develop clinically translatable treatments that yield widespread and lasting effects and 2) develop clinically accessible ways of identifying who will acquire benefit from a specific treatment approach. This study takes on these two challenges by investigating dose frequency (massed vs. distributed practice) effects and by identifying the language, cognitive and neural predictors of response to Intention treatment (INT), a novel word retrieval treatment. Specifically, the investigators will address the following aims:

Aim 1: To investigate dose frequency effects on maintenance and generalization of INT gains. Outcome measure: Word retrieval accuracy for trained and untrained words.

Aim 2: To identify the language and cognitive variables that predict response to m-INT vs. d-INT. Outcome measure: Language and cognitive ability as measured by standardized assessments.

Aim 3: To identify the neural predictors of response to m-INT vs. d-INT. Outcome measure: Tissue health and task activation location as measured by structural and functional MRI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aphasia Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessments will be conducted by study staff blind to treatment condition

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Massed Intention Treatment (massed-INT)

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

Group Type ACTIVE_COMPARATOR

Intention Treatment for Anomia

Intervention Type BEHAVIORAL

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

Distributed Intention Treatment (distributed-INT)

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

Group Type ACTIVE_COMPARATOR

Intention Treatment for Anomia

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intention Treatment for Anomia

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy D. Rodriguez, PhD

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Medical and Rehab Center, Decatur, GA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N3093-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise Effects on Word Learning
NCT03370471 COMPLETED NA
Augmenting Language Therapy for Aphasia: Levodopa
NCT01429077 COMPLETED PHASE2/PHASE3
MIT Intensive Treatment Study
NCT06213376 COMPLETED NA
Criterion-learning Based Naming Treatment in Aphasia
NCT06364709 ENROLLING_BY_INVITATION NA
Speech Entrainment for Aphasia Recovery
NCT04364854 COMPLETED PHASE2
Neuroplasticity Biomarkers in Aphasia
NCT06471127 RECRUITING NA