The aim of this pilot study is to investigate the feasibility and to gain preliminary information on the effectiveness of a cognitive rehabilitation program in patients with (severe) progressive MS, i.e. a speed of processing training (SPT).…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in cognitive performance and subjective well-being perceived on
cognitive functioning, mood, fatigue, and quality of life before and after the
interventions are the main outcome parameters.
Secondary outcome
Not applicable.
Background summary
Rationale: Worldwide, approximately one million patients suffer from the most
progressive forms of MS. Cognitive impairment is extremely prominent and
incapacitating, particularly in these patients, limiting their quality of life
to a great extent.
Recently, the cognitive profiles of patients with progressive MS requiring
assisted living were comprehensively described from a neuropsychological
perspective, demonstrating major problems in several cognitive domains, but
most profoundly in information processing speed (Kant et al., submitted for
publication).
Since there are no disease modifying treatment options available for patients
with progressive MS (contrary to patients in the relapsing remitting stage of
the disease), this group is in urgent need of options to improve their
cognition and quality of life to lower the burden of the disease.
In patients with relapsing remitting MS, significant improvement of cognitive
functioning is demonstrated after a variety of cognitive interventions (i.e.
retraining of function). Next to retraining cognitive functioning, research has
shown that psychoeducation and learning *tips and tricks* (i.e. learning
compensatory strategies) to cope with the cognitive deficits improve the
quality of life and subjective cognitive functioning significantly. Although
training of compensatory strategies already is provided as part of usual care,
cognitive function training is not. It is as yet unknown whether cognitive
function training is feasible and effective in progressive MS patients.
Study objective
The aim of this pilot study is to investigate the feasibility and to gain
preliminary information on the effectiveness of a cognitive rehabilitation
program in patients with (severe) progressive MS, i.e. a speed of processing
training (SPT).
Hypothesis: Speed of processing training and strategy training are expected to
be feasible in progressive MS patients, with adaptations to the standard
protocol. They are both expected to positively affect quality of life.
Moreover, SPT is expected to improve speed of processing and overall cognitive
functioning.
Study design
The proposed pilot study is a randomized controlled intervention study of a
well-defined cohort of 18 patients with severe progressive MS (9 participating
in speed of processing training, and 9 in a control group receiving i cognitive
strategy training focusing on memory). Quality of life and cognitive
functioning will be assessed before and directly after intervention.
Intervention
A computer based speed of processing training, based on the method of
retraining, will be provided for 5 weeks (2 times a week, 60 minutes per
session) to the experimental group (intensity to be adjusted when needed).
Patients in the control condition will participate in an internet skills
training with the same duration, intensity and frequency.
cognitive strategy training focusing on memory
Patients in the strategy training group will participate in a 10-week (once a
week, 2 hours per session) strategy training (coping with cognitive impairment)
which is given standard of care in Nieuw Unicum, and is based on a well
described standardized protocol (adjusted to the target population, keeping
cognitive load and intensity low).
Study burden and risks
Patients will need to undergo a 90 minutes neuropsychological assessment twice,
including questionnaires about their subjective wellbeing. The tests will be
administered at the clinic were the participants reside or are temporarily
admitted. Since the interventions are non-invasive, no adverse effects are
expected.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1) at least 18 years of age
2) confirmed diagnosis of progressive MS
3) mentally competent to give informed consent
4) able to follow instructions and to respond autonomously to questionnaires
5) sufficient motor skills to perform the computer-based trainings
Exclusion criteria
1) individuals with impaired vision to such extent that they cannot distinguish the stimuli of the SPT intervention
2) individuals with (a history of) other major neurological disorders (e.g. stroke)
3) individuals with current major psychiatric disorders (e.g. bipolar disorder)
4) individuals with a history (or current situation) of extensive drug abuse
5) no changes in medication use (antidepressants and psycho-active drugs) are allowed for the last 4 weeks (stable treatment regime)
6) individuals that already recently participated in cognitive rehabilitation (within the last year) are excluded from participation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL62300.029.17 |