Memory DisordersNCT03183453
Neuropsychological Rehabilitation of Spontaneous Confabulation: a Replica Study
A study testing Neuropsychological treatment in people with Memory Disorders, run by Monica Triviño Mosquera at 1 site in Spain.
Trial summary
Confabulators consistently generate false memories without intention to deceive and with great feeling of rightness. However, there is currently no known effective treatment for them. In order to fill this gap, we performed a neuropsychological treatment in two groups of confabulators: experimental vs. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Disorders
- What is being tested?
- Neuropsychological treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to 31 Jan 2018
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The presence of spontaneous confabulations after acute brain injury, for at least three months and without clinical improvement (interfering with the patient's daily life with frequent arguments and exhaustive supervision).
- The presence of momentary confabulations in the Spanish adaptation of Dalla Barba provoked confabulation interview.
- Prior to injury, all patients should be completely independent for daily living.
Who cannot join
- The presence of impairment in alertness.
- Dementia.
- Acute confusional state.
- A history of drug abuse.
- Psychiatric antecedents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Replica Study of a Neuropsychological Treatment for Patients Who Show Spontaneous Confabulation After Acquired Brain Injury
Confabulators consistently generate false memories without intention to deceive and with great feeling of rightness. However, there is currently no known effective treatment for them. In order to fill this gap, we performed a neuropsychological treatment in two groups of confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).
Now, we intend to replicate the treatment with a larger sample of confabulators and with other two control groups: non-confabulator patients with brain injury and healthy individuals
Read the detailed description
The treatment consisted of some brief material that patients had to learn and recall at both immediate and delayed moments. After both recollections, patients were given feedback about their performance (errors and correct responses). Pre-treatment and post-treatment measurements were administered.
Non-confabulator patients and healthy participants performed only the pre-treatment measurement.
- Conditions
- Memory Disorders
- Being tested
- Neuropsychological treatment
- Keywords
- Confabulations, Neuropsychological rehabilitation, Memory
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological treatmentBehavioural
Also called Confabulations treatment
Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological treatment | Experimental | The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits. Receives: Behavioral: Neuropsychological treatment |
| Non-confabulators control group | No intervention | Non-confabulators (brain injured patients but without confabulations) in this control group only performed the pre- and post-measurements without treatment. |
| Healthy control group | No intervention | Healthy participants in this control group only performed the pre- and post-measurements without treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of Confabulations
The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses.
Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the 3 sessions.
Measured: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Change in the number of correct responses
Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
Measured: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Change in the number of non-responses
Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
Measured: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Secondary outcomes (1)
Change in the number of errors in source attribution
After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves).
Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).
Measured: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startJul 2015
- Primary completion1 Sep 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monica Triviño Mosquera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monica Triviño Mosquera, San Rafael University Hospital, Granada, Spain
- Investigators
- Monica Triviño, PhD, Principal investigator, San Rafael University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183453
- Sponsor's protocol ID
- Conf-02
- Status last verified
- May 2018
- First submitted
- 25 Apr 2017
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gilboa A, Alain C, Stuss DT, Melo B, Miller S, Moscovitch M. Mechanisms of spontaneous confabulations: a strategic retrieval account. Brain. 2006 Jun;129(Pt 6):1399-414. doi: 10.1093/brain/awl093. Epub 2006 Apr 25.
PubMed 16638795Trivino M, Rodenas E, Lupianez J, Arnedo M. Effectiveness of a neuropsychological treatment for confabulations after brain injury: A clinical trial with theoretical implications. PLoS One. 2017 Mar 3;12(3):e0173166. doi: 10.1371/journal.pone.0173166. eCollection 2017.
PubMed 28257420Schnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008
Nahum L, Bouzerda-Wahlen A, Guggisberg A, Ptak R, Schnider A. Forms of confabulation: dissociations and associations. Neuropsychologia. 2012 Aug;50(10):2524-34. doi: 10.1016/j.neuropsychologia.2012.06.026. Epub 2012 Jul 7.
PubMed 22781813Ciaramelli E, Ghetti S, Borsotti M. Divided attention during retrieval suppresses false recognition in confabulation. Cortex. 2009 Feb;45(2):141-53. doi: 10.1016/j.cortex.2007.10.006. Epub 2008 Feb 6.
PubMed 19150516
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replica Study of a Neuropsychological Treatment for Patients Who Show Spontaneous Confabulation After Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03183453
- Acronym / sponsor ID
- Conf-02
- Conditions
- Memory Disorders
- Keywords
- Confabulations, Neuropsychological rehabilitation, Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Monica Triviño MosqueraUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 12 Jun 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.
Confabulators consistently generate false memories without intention to deceive and with great feeling of rightness. However, there is currently no known effective treatment for them. In order to fill this gap, we performed a neuropsychological treatment in two groups of confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).
Now, we intend to replicate the treatment with a larger sample of confabulators and with other two control groups: non-confabulator patients with brain injury and healthy individuals
Detailed description
The treatment consisted of some brief material that patients had to learn and recall at both immediate and delayed moments. After both recollections, patients were given feedback about their performance (errors and correct responses). Pre-treatment and post-treatment measurements were administered.
Non-confabulator patients and healthy participants performed only the pre-treatment measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological treatment | Experimental | Behavioral: Neuropsychological treatmentThe tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits. |
| Non-confabulators control group | No intervention | –Non-confabulators (brain injured patients but without confabulations) in this control group only performed the pre- and post-measurements without treatment. |
| Healthy control group | No intervention | –Healthy participants in this control group only performed the pre- and post-measurements without treatment. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of spontaneous confabulations after acute brain injury, for at least three months and without clinical improvement (interfering with the patient's daily life with frequent arguments and exhaustive supervision).
- The presence of momentary confabulations in the Spanish adaptation of Dalla Barba provoked confabulation interview.
- Prior to injury, all patients should be completely independent for daily living.
Key exclusion criteria (5 listed)
- The presence of impairment in alertness.
- Dementia.
- Acute confusional state.
- A history of drug abuse.
- Psychiatric antecedents.
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 |
|---|---|---|
| Neuropsychological treatmentAlso: Confabulations treatmentParticipants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment. | Behavioural | Neuropsychological treatment |
Primary outcome
Change in the number of Confabulations
Time frame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses. Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the 3 sessions.
Change in the number of correct responses
Time frame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
Change in the number of non-responses
Time frame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
1 secondary outcome
Change in the number of errors in source attribution
Time frame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).
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 29 May 2018.
- Background: PubMed 16638795Gilboa A, Alain C, Stuss DT, Melo B, Miller S, Moscovitch M. Mechanisms of spontaneous confabulations: a strategic retrieval account. Brain. 2006 Jun;129(Pt 6):1399-414. doi: 10.1093/brain/awl093. Epub 2006 Apr 25.
- Background: PubMed 28257420Trivino M, Rodenas E, Lupianez J, Arnedo M. Effectiveness of a neuropsychological treatment for confabulations after brain injury: A clinical trial with theoretical implications. PLoS One. 2017 Mar 3;12(3):e0173166. doi: 10.1371/journal.pone.0173166. eCollection 2017.
- BackgroundSchnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008
- Background: PubMed 22781813Nahum L, Bouzerda-Wahlen A, Guggisberg A, Ptak R, Schnider A. Forms of confabulation: dissociations and associations. Neuropsychologia. 2012 Aug;50(10):2524-34. doi: 10.1016/j.neuropsychologia.2012.06.026. Epub 2012 Jul 7.
- Background: PubMed 19150516Ciaramelli E, Ghetti S, Borsotti M. Divided attention during retrieval suppresses false recognition in confabulation. Cortex. 2009 Feb;45(2):141-53. doi: 10.1016/j.cortex.2007.10.006. Epub 2008 Feb 6.
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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.
Monica Triviño, PhD principal investigator
San Rafael University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological treatment in people with Memory Disorders, run by Monica Triviño Mosquera at 1 site in Spain.
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 3 inclusion and 5 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 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in the number of Confabulations (time frame: A first measure (pre-treatment) was recorded after the recruitment up maximum to 1 month. A second measure (post-treatment) after 3 weeks (that was the duration of the treatment).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183453, which also lists 5 linked publications.
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 29 May 2018.