Trial Outcomes & Findings for Neuropsychological Rehabilitation of Spontaneous Confabulation (NCT NCT02540772)

Last Updated: 2016-03-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

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 posted on

2016-03-07

Participant Flow

Patients were recruited during the period between April 2013 and April 2015 at the San Rafael Hospital where they were admitted for rehabilitation after acquired brain injury.

Due to the absence of confabulations in the Dalla Barba interview two participants were excluded. Another two participants were excluded because a deficit in alertness.

Participant milestones

Participant milestones
Measure	Neuropsychological Treatment 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. 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. 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.	No Treatment Patients in the control group only performed the baselines.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuropsychological Rehabilitation of Spontaneous Confabulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuropsychological Treatment n=10 Participants Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 Participants Patients in the control group only performed the baselines.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 14.3 • n=5 Participants	68.1 years STANDARD_DEVIATION 11.2 • n=7 Participants	66.0 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Neuropsychological Treatment n=10 Participants Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 Participants Patients in the control group only performed the baselines.
Number of Confabulations Pre baseline	30.0 Confabulations Standard Deviation 9.9	29.9 Confabulations Standard Deviation 13.8
Number of Confabulations Post baseline	8.1 Confabulations Standard Deviation 4.2	35.5 Confabulations Standard Deviation 11.3

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Neuropsychological Treatment n=10 Participants Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 Participants Patients in the control group only performed the baselines.
Number of Correct Responses Pre baseline	22.0 Correct responses Standard Deviation 13.6	20.9 Correct responses Standard Deviation 10.6
Number of Correct Responses Post baseline	42.6 Correct responses Standard Deviation 18.7	22.0 Correct responses Standard Deviation 8.9

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Neuropsychological Treatment n=10 Participants Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 Participants Patients in the control group only performed the baselines.
Number of Non-responses Pre baseline	26.3 Non-responses Standard Deviation 15.8	29.5 Non-responses Standard Deviation 11.8
Number of Non-responses Post baseline	22.3 Non-responses Standard Deviation 17.5	19.2 Non-responses Standard Deviation 8.8

SECONDARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Neuropsychological Treatment n=10 Participants Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 Participants Patients in the control group only performed the baselines.
Number of Errors in Source Attribution Pre baseline	25.1 Errors in source attribution Standard Deviation 6.1	25.7 Errors in source attribution Standard Deviation 12.5
Number of Errors in Source Attribution Post baseline	12.2 Errors in source attribution Standard Deviation 7.0	30.2 Errors in source attribution Standard Deviation 11.6

Adverse Events

Neuropsychological Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neuropsychological Treatment n=10 participants at risk Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 participants at risk Patients in the control group only performed the baselines.
Nervous system disorders Worsening of confabulations	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.	70.0% 7/10 • Number of events 7 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.
Nervous system disorders Worsening of Behavioral Disorders	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.

Other adverse events

Other adverse events
Measure	Neuropsychological Treatment n=10 participants at risk Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.	No Treatment n=10 participants at risk Patients in the control group only performed the baselines.
Nervous system disorders Worsening of memory	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.
Nervous system disorders Worsening of attention	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.
Nervous system disorders Worsening of working memory	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.
Nervous system disorders Worsening of executive functions	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.	0.00% 0/10 • One week A neuropsychological assessment and an interview to the relatives were administered before and after treatment to ensure that the treatment did not produce undesired effects on cognition (worsening of the confabulations) or behavior (severe behavioral disorders) in the patients. This assessment was administered in 3 sessions over a week.

Additional Information

Monica Triviño Mosquera

San Rafael University Hospital

Phone: 34958275700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place