Memory DisordersNCT02540772

Neuropsychological Rehabilitation of Spontaneous Confabulation

A study testing Neuropsychological treatment in people with Memory Disorders, run by Monica Triviño Mosquera at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 86 years
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: 20 participants
Where: 1 siteSpain
Study dates: Apr 2013to Apr 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 86 years
All sexes
No healthy volunteers
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 alcohol or drug abuse.
Psychiatric antecedents.

Trial locations and contacts

1 site in 1 country.

Spain1 site

San Rafael University Hospital
Granada, Granada, 18001

Other trials in Spain

About this study

Official title: Study of the Neuroanatomical Circuits, Predictors and Prognostic Factors of Spontaneous Confabulation: Designing an Assessment and Rehabilitation Program

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, the aim of this trial was to design a neuropsychological treatment based on the current theoretical models and test it experimentally in two groups of confabulators: experimental vs. control. 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 baselines were administered. Confabulators in the control group performed the baselines without treatment, and were then offered the treatment after the second baseline.

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 groups in NCT02540772
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
No treatment	No intervention	Patients in the control group only performed the baselines.

What is being measured

The primary outcome is the main question the study is designed to answer.

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 baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).
Measured: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them
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).
The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).
Measured: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them
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).
The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).
Measured: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

Secondary outcomes (1)

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).
The values in the table represent the mean of errors in source attribution for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).
Measured: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Apr 2015

First posted4 Sep 2015 (estimated)
Study startApr 2013
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02540772
Sponsor's protocol ID: Conf-01
Status last verified: Feb 2016
First submitted: 15 Aug 2015
Last updated: 7 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
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 16638795
Moscovitch M, Melo B. Strategic retrieval and the frontal lobes: evidence from confabulation and amnesia. Neuropsychologia. 1997 Jul;35(7):1017-34. doi: 10.1016/s0028-3932(97)00028-6.
PubMed 9226662
Schnider 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 22781813
Ciaramelli 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
Dayus B, Van den Broek MD. Treatment of stable delusional confabulations using self-monitoring training. Neuropsychol Rehabil, 2000; 10(4):415-427.
Del Grosso Destreri N, Farina E, Calabrese E, Pinardi G, Imbornone E, Mariani C. Frontal impairment and confabulation after herpes simplex encephalitis: A case report. Arch Phys Med Rehabil. 2002 Mar;83(3):423-6. doi: 10.1053/apmr.2002.29646.
PubMed 11887126
Dalla Barba G, Decaix C. "Do you remember what you did on March 13, 1985?" A case study of confabulatory hypermnesia. Cortex. 2009 May;45(5):566-74. doi: 10.1016/j.cortex.2008.03.009. Epub 2008 Jun 5.
PubMed 18621364

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Neuroanatomical Circuits, Predictors and Prognostic Factors of Spontaneous Confabulation: Designing an Assessment and Rehabilitation Program
ClinicalTrials.gov ID: NCT02540772
Acronym / sponsor ID: Conf-01
Conditions: Memory Disorders
Keywords: Confabulations, Neuropsychological rehabilitation, Memory
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Monica Triviño MosqueraUniversity, hospital or other
Study start: Apr 2013
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 4 Sep 2015 (estimated)
Results: Posted 7 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

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.
No treatment	No intervention	–Patients in the control group only performed the baselines.

Who may qualify

Ages: 35 to 86 years
Sex: All
Healthy volunteers: Not 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 alcohol or 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

Number of Confabulations
Time frame: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them
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 baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).
Number of Correct Responses
Time frame: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them
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). The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).
Number of Non-responses
Time frame: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them
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). The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment).

1 secondary outcome

Number of Errors in Source Attribution
Time frame: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them

Results and safety

Results posted to the registry on 7 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neuropsychological Treatment	10	10
No Treatment	10	10

Primary outcome: Number of Confabulations

Time frame: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them. Mean (Standard Deviation). Unit: Confabulations

Measure	Neuropsychological Treatment n = 10	No Treatment n = 10
Pre baseline	30.0 (9.9)	29.9 (13.8)
Post baseline	8.1 (4.2)	35.5 (11.3)

Population analysed: We used preliminary data from the first 5 patients using the G\*Power software to calculate the sample size. From them, to detect differences through a Student t-test considering the significance level is 5%, the sample size was estimated in 7 subjects per group with an alpha of 0.95. We expanded to 10 to ensure greater power.

Primary outcome: Number of Correct Responses

Measure	Neuropsychological Treatment n = 10	No Treatment n = 10
Pre baseline	22.0 (13.6)	20.9 (10.6)
Post baseline	42.6 (18.7)	22.0 (8.9)

Population analysed: Minimum number for comparison of means calculated with G\*Power software (see Analysis Population Description of previous outcome measure data, i.e., confabulations).

Primary outcome: Number of Non-responses

Measure	Neuropsychological Treatment n = 10	No Treatment n = 10
Pre baseline	26.3 (15.8)	29.5 (11.8)
Post baseline	22.3 (17.5)	19.2 (8.8)

Population analysed: Minimum number for comparison of means calculated with G\*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: One week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neuropsychological Treatment	0 of 10 (0%)	0 of 10 (0%)	Not reported
No Treatment	7 of 10 (70%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 9226662Moscovitch M, Melo B. Strategic retrieval and the frontal lobes: evidence from confabulation and amnesia. Neuropsychologia. 1997 Jul;35(7):1017-34. doi: 10.1016/s0028-3932(97)00028-6.
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.
BackgroundDayus B, Van den Broek MD. Treatment of stable delusional confabulations using self-monitoring training. Neuropsychol Rehabil, 2000; 10(4):415-427.
Background: PubMed 11887126Del Grosso Destreri N, Farina E, Calabrese E, Pinardi G, Imbornone E, Mariani C. Frontal impairment and confabulation after herpes simplex encephalitis: A case report. Arch Phys Med Rehabil. 2002 Mar;83(3):423-6. doi: 10.1053/apmr.2002.29646.
Background: PubMed 18621364Dalla Barba G, Decaix C. "Do you remember what you did on March 13, 1985?" A case study of confabulatory hypermnesia. Cortex. 2009 May;45(5):566-74. doi: 10.1016/j.cortex.2008.03.009. Epub 2008 Jun 5.

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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 7 Mar 2016. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Confabulations (time frame: Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them). 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 NCT02540772, which also lists 8 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 7 Mar 2016.