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
About this trial
This is an interventional treatment trial for Aphasia
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
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
NCT ID
NCT03381313
First Posted
December 18, 2017
Last Updated
December 21, 2017
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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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