NCT02664506

Brief Summary

The aim of this research is to translate a theory of the cognitive relationship between verbal short--term memory (STM) and word processing impairments in aphasia to treatment approaches for language impairment in aphasia. It has been proposed that the co-occurrence of these impairments is due to a disruption of cognitive processes that support both abilities: maintenance of activated semantic and phonological representations of words, hereafter the 'activation--maintenance hypothesis'. This hypothesis will be tested in the context of a treatment approach that aims to improve word processing and verbal STM abilities. The grant supporting this work has ended. therefore, participants are entered into the study by invitation only.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

11.8 years

First QC Date

January 15, 2016

Last Update Submit

April 9, 2024

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Verbal Short-Term Memory (STM) Span at 6 weeks

    It is expected that this treatment will increase verbal STM span (primary)

    Baseline and 6 weeks

Secondary Outcomes (2)

  • Change in proportion of words retrieved in picture naming

    Post treatment, after 6 weeks of treatment

  • Discourse measures, changes in rates of context information units

    Post treatment, after 6 weeks of treatment

Study Arms (1)

Word repetition after a tiem delay

EXPERIMENTAL

People with Aphasia and Short-Term Memory impairment will receive a behavioral treatment: Word repetition after a time delay. This is the intervention: repetition of words after a 5 or 10 second delay.

Behavioral: Word repetition after a time delay.

Interventions

Word repetition after a time delay.BEHAVIORAL

This is a behavioral intervention, Word repetition after a time delay. Individuals listen to words and repeat them after 5 or 10 seconds.

Also known as: Repetition after delay
Word repetition after a tiem delay

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aphasia
  • Single left hemisphere lesions
  • Right handed
  • At least six months post-stroke
  • Aged 21 to 80
  • High-school educated with English as their primary language
  • Passed an audiometric pure tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear (with or without correction)
  • Demonstrate adequate vision with or without correction.
  • Will not exclude individuals with a mild apraxia of speech or mild dysarthria of speech.

You may not qualify if:

  • History of mental illness
  • Alcohol/substance abuse
  • Pregnant
  • Unable to personally give informed consent
  • Control participants:
  • Aged 21 to 80
  • High school educated or above
  • Pass an audiometric pure tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear.
  • History of neurological disease or language disability
  • Histories for mental illness
  • Alcohol/substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19121, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nadine Martin, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nadine Martin, Ph.D.

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 27, 2016

Study Start

March 1, 2014

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)