The primary objective is:To investigate whether a two-weeks intervention with cerebellar anodal tDCS could improve CCAS severity in patients with cerebellar disorders compared to sham stimulation.Secondary objectives are:• To investigate whether a…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in neuropsychological performance (using a composite z-score
covering relevant domains affected in CCAS) between 6 weeks post-treatment and
pre-treatment, real vs. sham stimulation.
Secondary outcome
• The absolute change on the Scale for the Assessment and Rating of ataxia
(SARA)
• EQ-5d
• The shortened 32-item version of the Profile of Mood States (POMS)
• Cerebellar cognitive affective/Schmahmann syndrome (CCAS) scale
• Possible tDCS-related side effects
• Percentage of patients in both conditions that correctly guess to which
groups they have been randomized
• Exploratory outcomes: correlations between response to intervention and
relevant patient and disease-related factors (e.g. age, stroke vs. degenerative
disease).
Other study parameters:
• Age
• Gender
• Age at disease onset
• Lesion mapping on available clinical MRI (for young stroke patients)
Background summary
Cerebellar disorders are relatively frequent, with at least a couple of
thousand patients in the Netherlands. These disorders do not only cause
disturbed coordination (ataxia), but also lead to cognitive and affective
problems that are, however, often neglected in clinical settings. The
prevalence of this cerebellar cognitive affective syndrome (CCAS) is probably
around 80% in patients with both static and progressive cerebellar disorders.
CCAS has a huge impact and contributes significantly to the perceived impact in
daily life and reduced quality of life. CCAS aries due to disturbed connections
between the cerebellum and mainly frontal cortical areas involved in the
regulation of cognition and emotion. Earlier studies have indicated that these
functional couplings can be improved by non-invasive brain stimulation (NIBS).
With this explorative trial, we here test the effect of cerebellar transcranial
direct current stimulation (tDCS) on CCAS in 40 patients with cerebellar
ataxias. There is an increasing interest in the application of NIBS in
neurology and psychiatry, evidenced for example by the approval of NIBS as a
treatment of refractory depression in the Netherlands. A positive outcome of
this trial proposed here would mean that a relatively easy, quick,
standardized, and low cost treatment for CCAS in patients with cerebellar
ataxias would be available. Furthermore, it will stimulate further research
into this intervention in other brain disorders.
Study objective
The primary objective is:
To investigate whether a two-weeks intervention with cerebellar anodal tDCS
could improve CCAS severity in patients with cerebellar disorders compared to
sham stimulation.
Secondary objectives are:
• To investigate whether a two-weeks treatment with cerebellar anodal tDCS
could improve motor symptoms in these patients compared to sham stimulation.
• To investigate whether a two-weeks treatment with cerebellar anodal tDCS in
these patients influences mood and quality of life.
• To investigate the dynamics of a possible tDCS effect on CCAS over the course
of one year.
• To explore whether certain patient characteristics modulate possible tDCS
effects on CCAS.
Study design
Explorative, randomized (1:1), sham-controlled, double blind, single-center
trial
Intervention
Patients will be randomized to either real or sham cerebellar tDCS; an
increasingly used, short, cheap, and non-invasive tool that modulates
cerebellar excitability using a pair of electrodes.
Study burden and risks
The load on patients consists predominantly of the time spent on the project,
i.e. tDCS 5 days/week for 2 consecutive weeks and the follow-up visits at 10,
42, 90, 180 and 365 days. During the study visits, patients are subjected to
neuropsychological tests, neurological examination and are asked to fill in the
aforementioned questionnaires for quality of life and mood. The intervention
(tDCS) is non-invasive and without significant side effects (*negligible
risk*).
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
Minimum age of 16, and:
A diagnosis of degenerative cerebellar ataxia, or:
A diagnosis of cerebellar stroke below age of 65 years, and:
CCAS, measured as impairment on a brief neuropsychological test battery (7
sets) with 3 or more tests scoring below 1.5 SD or 2 tests below 2 SD
Exclusion criteria
• Contra-indications for tDCS, i.e. metallic implants near the electrodes or
the presence of unstable medical conditions or any illness that may increase
the risk of stimulation, e.g. epilepsy or eczema under the electrodes.
• Significant comorbidities that interfere with activities of daily life.
• Co-morbid neurological conditions.
• Use of neurotropic medication.
• Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL73572.091.20 |