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Neuropsychological Rehabilitation of Spontaneous Confabulation

Primary Purpose

Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuropsychological treatment
Sponsored by
Monica Triviño Mosquera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorders focused on measuring Confabulations, Neuropsychological rehabilitation, Memory

Eligibility Criteria

35 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The presence of impairment in alertness.
  • Dementia.
  • Acute confusional state.
  • A history of alcohol or drug abuse.
  • Psychiatric antecedents.

Sites / Locations

  • San Rafael University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neuropsychological treatment

No treatment

Arm Description

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.

Patients in the control group only performed the baselines.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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).

Full Information

First Posted
August 15, 2015
Last Updated
February 9, 2016
Sponsor
Monica Triviño Mosquera
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1. Study Identification

Unique Protocol Identification Number
NCT02540772
Brief Title
Neuropsychological Rehabilitation of Spontaneous Confabulation
Official Title
Study of the Neuroanatomical Circuits, Predictors and Prognostic Factors of Spontaneous Confabulation: Designing an Assessment and Rehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Monica Triviño Mosquera

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders
Keywords
Confabulations, Neuropsychological rehabilitation, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuropsychological treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Patients in the control group only performed the baselines.
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological treatment
Other Intervention Name(s)
Confabulations treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Confabulations
Description
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).
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
Title
Number of Correct Responses
Description
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).
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
Title
Number of Non-responses
Description
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).
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
Secondary Outcome Measure Information:
Title
Number of Errors in Source Attribution
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: The presence of impairment in alertness. Dementia. Acute confusional state. A history of alcohol or drug abuse. Psychiatric antecedents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Triviño, PhD
Organizational Affiliation
San Rafael University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Rafael University Hospital
City
Granada
ZIP/Postal Code
18001
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16638795
Citation
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.
Results Reference
background
PubMed Identifier
9226662
Citation
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.
Results Reference
background
Citation
Schnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008.
Results Reference
background
PubMed Identifier
22781813
Citation
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.
Results Reference
background
PubMed Identifier
19150516
Citation
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.
Results Reference
background
Citation
Dayus B, Van den Broek MD. Treatment of stable delusional confabulations using self-monitoring training. Neuropsychol Rehabil, 2000; 10(4):415-427.
Results Reference
background
PubMed Identifier
11887126
Citation
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.
Results Reference
background
PubMed Identifier
18621364
Citation
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.
Results Reference
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Neuropsychological Rehabilitation of Spontaneous Confabulation

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