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Classical Conditioning Training for Aphasia. A Telemedicine Approach.

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conditioned word repetition training
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aphasic patients with word finding difficulty
  • Must be able to repeat single words

Exclusion Criteria:

  • Severe cognitive impairment
  • Impaired single word comprehension

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Anomic Patients

    Arm Description

    Pure Anomic Patients underwent to conditioned word repetition training or traditional one.

    Outcomes

    Primary Outcome Measures

    Training effect in the treated word set
    Differences between accuracy pre and post in the treated word set

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2017
    Last Updated
    December 21, 2017
    Sponsor
    I.R.C.C.S. Fondazione Santa Lucia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03381313
    Brief Title
    Classical Conditioning Training for Aphasia. A Telemedicine Approach.
    Official Title
    Improving Word Repetition Training Using Classical Conditioning With a Computer Based Telemedicine Approach: Evidence From a Study on 12 Person With Chronic Aphasia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (Actual)
    Primary Completion Date
    November 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    I.R.C.C.S. Fondazione Santa Lucia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aimed at investigating the suitability of a classical conditioning for the treatment of anomic disorder. In this study 12 patients suffering from pure anomia in the chronic stage of the disease underwent a word repetition training with a computerized telemedicine protocol. Each patient trained two word sets, one in a conditioned and the other in a non-conditioned training modality; a third non trained set served as control set.
    Detailed Description
    In this study, a computer based word repetition protocol was administered at the distance to 12 pure anomic patients in the chronic stage of the disease. The to be repeated words were presented alongside the corresponding pictures. The timing of word and picture presentation was manipulated in order to investigate the suitability of classical conditioning to reteach the association between pictures and their names. Data were analyzed at the group and at the single subject level with the aim of establishing the relative efficacy of the conditioned and non-conditioned word-repetition modality and the cognitive features predicting therapy success. In keeping with preliminary results obtained on a single case study, conditioning turned out to improve therapy gain at the group level. Moreover, hints were found suggesting less generalization to untreated words in conditioned compared to non-conditioned training. Non-word repetition skills was the only feature in the participants cognitive profile which was reliably linked to the therapy outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    12 patients suffering from pure anomia in the chronic stage of the disease underwent a word repetition training with a computerized telemedicine protocol. Each patient trained two word sets, one in a conditioned and the other in a non-conditioned training modality; a third non trained set served as control.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anomic Patients
    Arm Type
    Experimental
    Arm Description
    Pure Anomic Patients underwent to conditioned word repetition training or traditional one.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Conditioned word repetition training
    Intervention Description
    In the classical conditioning training the onset of the visual stimulus preceded that of the auditory stimulus with a short onset asynchrony, and both stimuli co-terminated. By contrast, in the training without conditioning the auditory stimulus was administered first and the visual stimulus appeared short after the off-set of the auditory one.
    Primary Outcome Measure Information:
    Title
    Training effect in the treated word set
    Description
    Differences between accuracy pre and post in the treated word set
    Time Frame
    immediately before and immediately after the training protocol (duration of the training protocol: 6 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aphasic patients with word finding difficulty Must be able to repeat single words Exclusion Criteria: Severe cognitive impairment Impaired single word comprehension
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giovanni A Carlesimo, MD
    Organizational Affiliation
    I.C.C.S Fondazione Santa Lucia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Classical Conditioning Training for Aphasia. A Telemedicine Approach.

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