Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02118480 |
| Other study ID # |
NSMC-001-UD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 15, 2014 |
| Last updated |
January 22, 2018 |
| Start date |
June 2012 |
| Est. completion date |
June 2013 |
Study information
| Verified date |
January 2018 |
| Source |
University of Deusto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study design was a parallel-group randomized trial with equal randomization. Recruitment
and enrollment were conducted between June 2012 and January 2013. At base-line, clinical,
cognitive and functional data was collected. Afterwards, the participants were randomly
allocated to either the REHACOP group or the Control group. During 3 months the intervention
with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate
the changes in clinical, cognitive and functional measures. Post-treatment assessment
(finished by June 2013) was performed within the first week after completing the
intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at
changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological
and neuroimaging assessements was also performed.
Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to
improve cognition, clinical symptoms and functional disability of patients with Parkinson
disease (PD).
Description:
Assessment protocol:
- Cognitive Evaluation: The cognitive battery included assessments to evaluate processing
speed, verbal learning and memory, visual learning and memory and executive functioning. All
cognitive measures were converted into Z-scores based on the pooled PD group, and the sign of
some measures was adjusted so that higher scores indicated better cognitive performance. All
composite cognitive domains maintained satisfactory internal consistency. Processing Speed
(Cronbach's α = 0.85) was quantified based on the Trail Making Test-A and Salthouse Letter
Comparison Test. For verbal learning and memory (α = 0.88), learning and long-term recall
performance on the Hopkins Verbal Learning Test (version 2 at baseline and 4 at
post-treatment) were utilized. For visual learning and memory (α = 0.96), learning and
long-term recall performance on the Brief Visual Memory Test (version 1 at baseline and 3 at
post-treatment) were used (α = 0.96). Executive functioning (α = 0.78) was determined based
on the Stroop test, using the word-color and interference scores.
Theory of mind (TOM). The strange stories test (Happé test) was administered to evaluate TOM.
Four different stories (concerning double bluff, mistakes, persuasion and white lies) were
administered at baseline and follow-up, and they were summed into a total TOM score with a
possible range of 0 to 8. Higher scores indicate better TOM.
- Premorbid intelligence quotient and cognitive reserve. The Accentuation Reading Test
(TAP), the Spanish version of the National Adult Reading Test (NART), was administered
to calculate an estimation of each patient´s premorbid intelligence. The scale ranged
from 0 to 30. Cognitive reserve was estimated using the Cognitive Reserve questionnaire.
This 15-item multiple-choice questionnaire includes questions about education/culture,
working activity, leisure and hobbies, physical activities and social activities. Higher
scores indicate a better cognitive reserve, and the scale ranged from 0 to 26.
- Global cognitive status. The Mini-Mental State Examination (MMSE) was administered to
obtain a general mental status score.
- Medication use. Medications, dosages and dose frequencies were used to calculate the
levodopa-equivalent daily dose (mg/day) (LEDD).
- PD assessment. The Unified Parkinson's Disease Rating Scale and the Hoehn & Yahr scale
were used for the assessment of the course and stage of the disease.
- Depressive symptoms. Geriatric Depression Scale (GDS-15) includes 15 items. Higher
scores represent a higher degree of depression (range from 0 to 15).
- Neuropsychiatric symptoms. The NPI-Q was administered to evaluate neuropsychiatric
symptoms. The test includes 10 items (delusions, hallucinations, agitation/aggression,
depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability and
aberrant motor behavior). These sub-scales were summed into a total score with a
possible range of 0 to 120. Higher scores indicate more frequent and severe
neuropsychiatric symptoms.
- Apathy. The Lille apathy rating scale consists of 33 items, including 9 sub-scales
(everyday productivity, interests, taking initiative, novelty seeking/motivation,
emotional responses, concern, social life and self-awareness). These sub-scales were
summed into a total apathy score with a possible range of -36 to 36. Lower scores
indicate less apathy.
- Functional disability. Functional disability was self administered using the World
Health Organization Disability Assessment Schedule II (WHO-DAS II), short version (12
items).
Description of the intervention:
- REHACOP is a structured program using paper-pencil tasks and it is based on the
principles of restoration, compensation and optimization with a gradually increasing
level of cognitive effort and demand. REHACOP trains different cognitive domains, such
as attention, memory, processing speed, language, executive functioning and social
cognition. Additionally, the program includes one unit related to functional outcome:
activities of daily living. REHACOP includes up to 300 different tasks hierarchically
organized into at least three levels of difficulty and subtypes of abilities. Several
tasks are timed, so processing speed is trained throughout various modules. Once a basic
cognitive strategy has been trained and well acquired, the therapist transitions the
program to the next level. The program format allows for either individual or group
sessions (between 5 and 8 patients per group), although for the purpose of this study,
group sessions were chosen. In this study, two psychologists conducted the REHACOP group
attending 60-minute-long sessions 3 days per week at Parkinson Disease Association
Biskay (ASPARBI) (two groups) or the Hospital of Galdakao (one group). Specifically,
REHACOP group remediation with PD patients consisted of: Attention unit (4 weeks)
training sustained, selective, alternant and divided attention; Memory unit (3 weeks)
focusing on visual and verbal learning, recall and recognizing memory; Language unit (3
weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension,
abstract language; Executive functions unit (2 weeks) training cognitive planning,
proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind,
social reasoning and moral dilemmas.
- Occupational Activities: The Control group consisted of occupational group activities
conducted by a psychologist at ASPARBI. The activities included drawing, reading the
daily news and constructing using different materials (such as paper or wood). These
activities were accomplished in a group format and with the same frequency as the
implementation of REHACOP in the experimental group.
A subset of the sample will also complete a pre and post neuroimaging to evaluate changes in
structural and functional brain activation.
