Genetic and Cognitive Predictors of Aphasia Treatment Response

NCT05179538 | Active Not Recruiting

• 1 other identifier: 60066189
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Aphasia, or language impairment after a stroke, affects approximately 2 million people in the United States, with an estimated 180,000 new cases each year. The medical community cannot predict how well someone with aphasia will respond to treatment, as some people with aphasia are poor responders to intervention even when participating in empirically supported treatments. There is a strong likelihood that genetics play a role in language recovery after stroke, but very little research has been dedicated to investigating this link. This study will investigate whether two genes and cognitive abilities, such as memory, predict responsiveness to aphasia therapy for word-retrieval difficulties.

Conditions

Aphasia

Outcome Measures

Primary Outcomes (2)

• Percent of pictures named correctly

  Picture-naming score changes from baseline to post-treatment.

  from baseline to 1 month

• Percentage of pictures named correctly

  Picture-naming score changes from post-treatment to follow up.

  4 months

Secondary Outcomes (2)

• percentage of definitions named correctly

  after 1 month

• Percentage of untrained pictures named correctly

  after 1 month

Study Arms (1)

Single Arm Treatment

EXPERIMENTAL

Cued picture naming therapy will be delivered to all participants. There will be four cohorts of participants based on BDNF and ApoE genotypes.

Behavioral: Cued picture-naming therapy

Interventions

Cued picture-naming therapy BEHAVIORAL

The proposed study will administer Cued Picture-Naming Treatment (CPNT) four days per week for four weeks (i.e. 16 sessions). During therapy, participants will attempt to name eight consecutive presentations of the same black and white picture, for each of the 20 pictures, with cueing from the administrator. Trials will include (1) independent naming, (2) orthographic cueing (i.e. the written word beneath the picture.), (3) repeating, (4) naming after a short delay (i.e. approximately three seconds), (5)semantic cueing (i.e. three cues providing semantic information about the target will be spoken to the participant by the clinician), (6) phonological cueing (i.e. the first sound and letter will be spoken by the clinician), (7) repeating, and (8) naming after a short delay. The administrator will provide the correct response for each incorrect participant response and will ask the participant to repeat it.

Single Arm Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least six months post-onset of a single left-hemisphere stroke
• Chronic aphasia
• Anomia (word-retrieval deficits)
• Native English Speaker.

You may not qualify if:

• Severe motor speech disorders
• Severe auditory comprehension deficits
• Severe depression.
• Diffuse injury or disease of the brain
• Uncorrected vision or hearing difficulties
• Contraindications for MRI (e.g. cardiac pacemaker, ferrous metal implants, claustrophobia, pregnancy).

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stacy M Harnish, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Speech-language pathologists who will be providing assessments and therapy will be blinded to participant genotypes.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be four subgroups based on the expression of BDNF and ApoE.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: January 5, 2022
• Study Start: October 23, 2020
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)