Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02540772
Other study ID # Conf-01
Secondary ID
Status Completed
Phase N/A
First received August 15, 2015
Last updated February 9, 2016
Start date April 2013
Est. completion date April 2015

Study information

Verified date February 2016
Source San Rafael University Hospital, Granada, Spain
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 86 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Neuropsychological 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.

Locations

Country Name City State
Spain San Rafael University Hospital Granada

Sponsors (1)

Lead Sponsor Collaborator
Monica Triviño Mosquera

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View 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. — View Citation

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. — View 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. Epub 2006 Apr 25. — View Citation

Moscovitch M, Melo B. Strategic retrieval and the frontal lobes: evidence from confabulation and amnesia. Neuropsychologia. 1997 Jul;35(7):1017-34. — View 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. — View Citation

Schnider A. The confabulating mind. How the brain creates reality. Oxford: Oxford University Press; 2008.

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
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 No
Primary 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).
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 No
Primary 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).
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 No
Secondary 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).
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 No
See also
  Status Clinical Trial Phase
Recruiting NCT03894254 - Predictive Factors of Autonomy Loss in Real-life Cohort N/A
Not yet recruiting NCT03507985 - Attention and Memory Disorders Related to Acute Morphine
Terminated NCT02521558 - Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease N/A
Completed NCT00355498 - Amyloid Plaque and Tangle Imaging in Aging and Dementia
Completed NCT00010920 - Preventing Cognitive Decline With Alternative Therapies Phase 3
Not yet recruiting NCT04079075 - Multiple Interventions to Prevent Cognitive Decline N/A
Completed NCT02185222 - Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint Phase 3
Completed NCT00289471 - Identifying Patients With Dementia in Primary Care N/A
Terminated NCT00548327 - The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype Phase 2
Completed NCT00387062 - Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment Phase 1
Completed NCT00403507 - Exercise Treatment of Mild-Stage Probable Alzheimer's Disease Phase 2
Completed NCT04587583 - WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers Phase 1/Phase 2
Completed NCT02843529 - Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) N/A
Active, not recruiting NCT03205709 - Cognitive Training and Neuroplasticity in Mild Cognitive Impairment N/A
Recruiting NCT05509075 - Nutraceuticals and Functional Foods
Recruiting NCT05065450 - Amygdala Memory Enhancement N/A
Recruiting NCT05929144 - Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases N/A
Active, not recruiting NCT03661034 - Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study) N/A
Completed NCT02333942 - Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia
Completed NCT02236416 - Physical Exercise for Prevention of Dementia N/A