- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381313
Classical Conditioning Training for Aphasia. A Telemedicine Approach.
December 21, 2017 updated by: Giovanni Augusto Carlesimo, I.R.C.C.S. Fondazione Santa Lucia
Improving Word Repetition Training Using Classical Conditioning With a Computer Based Telemedicine Approach: Evidence From a Study on 12 Person With Chronic Aphasia.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aphasic patients with word finding difficulty
- Must be able to repeat single words
Exclusion Criteria:
- Severe cognitive impairment
- Impaired single word comprehension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anomic Patients
Pure Anomic Patients underwent to conditioned word repetition training or traditional one.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training effect in the treated word set
Time Frame: immediately before and immediately after the training protocol (duration of the training protocol: 6 weeks)
|
Differences between accuracy pre and post in the treated word set
|
immediately before and immediately after the training protocol (duration of the training protocol: 6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giovanni A Carlesimo, MD, I.C.C.S Fondazione Santa Lucia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2014
Primary Completion (ACTUAL)
November 1, 2017
Study Completion (ACTUAL)
November 1, 2017
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (ACTUAL)
December 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 26, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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