AphasiaNCT03381313
Classical Conditioning Training for Aphasia. A Telemedicine Approach.
A study testing Conditioned word repetition training in people with Aphasia, run by I.R.C.C.S. Fondazione Santa Lucia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Conditioned word repetition training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aphasic patients with word finding difficulty
- Must be able to repeat single words
Who cannot join
- Severe cognitive impairment
- Impaired single word comprehension
About this study
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.
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.
Read the 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.
- Conditions
- Aphasia
- Being tested
- Conditioned word repetition training
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned word repetition trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Anomic Patients | Experimental | Pure Anomic Patients underwent to conditioned word repetition training or traditional one. Receives: Behavioral: Conditioned word repetition training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training effect in the treated word set
Differences between accuracy pre and post in the treated word set
Measured: immediately before and immediately after the training protocol (duration of the training protocol: 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study startApr 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Augusto Carlesimo, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Giovanni A Carlesimo, MD, Principal investigator, I.C.C.S Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381313
- Sponsor's protocol ID
- 2
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03381313
- Acronym / sponsor ID
- 2
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anomic Patients | Experimental | Behavioral: Conditioned word repetition trainingPure Anomic Patients underwent to conditioned word repetition training or traditional one. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aphasic patients with word finding difficulty
- Must be able to repeat single words
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- Impaired single word comprehension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioned word repetition trainingIn 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. | Behavioural | Anomic Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni A Carlesimo, MD principal investigator
I.C.C.S Fondazione Santa Lucia
Questions about this trial
What is this clinical trial studying?
A study testing Conditioned word repetition training in people with Aphasia, run by I.R.C.C.S. Fondazione Santa Lucia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training effect in the treated word set (time frame: immediately before and immediately after the training protocol (duration of the training protocol: 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.