The primary objective of this study is:* To investigate whether a two-weeks intervention with cerebellar anodal tDCS could improve ataxia severity in SCA3 patients compared to sham stimulation.Secondary objectives of this study are:* To investigate…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the absolute change on the Scale for the
Assessment and Rating of Ataxia (SARA).
Secondary outcome
Secondary outcome measures include SCA Functional Index (motor performance),
Inventory of Non-Ataxia Signs count (extracerebellar involvement), EQ-5d
(quality of life), Patient Health Questionnaire-9 (depression), short version
of the POMS (mood states), Cerebellar Cognitive Affective Syndrome scale
(specifically cerebellar cognitive functions), Activities of Daily Living,
amount of medical consumption, percentage and timing of conditioned responses
using a delay eyeblink classical conditioning (EBCC) paradigm (motor learning),
and cerebellar brain inhibition using transcranial magnetic stimulation (TMS).
Background summary
Spinocerebellar ataxia type 3 (SCA3) is the most common subtype among the
autosomal dominant cerebellar ataxias, a group of debilitating, progressive
conditions for which currently no disease-specific treatment * i.e. aimed at
the underlying molecular and cellular processes * is available. Evidence-based
options for symptomatic treatment of ataxia are also limited. Recent
investigations in a heterogeneous group of both hereditary and acquired ataxias
show promising results of cerebellar transcranial direct current stimulation
(tDCS). We here aim to test the hypothesis that increasing cerebellar
excitability through cerebellar tDCS improves ataxia symptoms in a homogeneous
cohort of SCA3 patients.
Study objective
The primary objective of this study is:
* To investigate whether a two-weeks intervention with cerebellar anodal tDCS
could improve ataxia severity in SCA3 patients compared to sham stimulation.
Secondary objectives of this study are:
* To investigate whether a two-weeks treatment with cerebellar anodal tDCS
could improve various non-motor symptoms in SCA3 patients compared to sham
stimulation.
* To investigate whether a two-weeks treatment with cerebellar anodal tDCS in
SCA3 patients enhances their ability to acquire conditioned response in a
delayed eyeblink classical conditioning paradigm compared to sham stimulation.
* To investigate whether a two-weeks treatment with cerebellar anodal tDCS in
SCA3 modulates cerebellar brain inhibition pathways compared to sham
stimulation.
Study design
Double-blind, randomized (1:1), sham-controlled, single-center exploratory
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 3, 6,
and 12 months. Furthermore, they are asked to fill in the aforementioned
questionnaires. All measurements (tDCS, TMS, and EBCC) are 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
* A proven SCA3 mutation (ATXN3 gene).
* Age * 16 years.
* SARA score * 20 (on a scale of 0 to 40).
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.
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 | NL65454.091.18 |
| OMON | NL-OMON21004 |