Reigniting the little brain: an exploratory trial of cerebellar transcranial direct current stimulation in SCA3
Completed
- Conditions
- Spinocerebellar ataxia type 310028037
- Registration Number
- NL-OMON46775
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the absolute change on the Scale for the<br /><br>Assessment and Rating of Ataxia (SARA).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include SCA Functional Index (motor performance),<br /><br>Inventory of Non-Ataxia Signs count (extracerebellar involvement), EQ-5d<br /><br>(quality of life), Patient Health Questionnaire-9 (depression), short version<br /><br>of the POMS (mood states), Cerebellar Cognitive Affective Syndrome scale<br /><br>(specifically cerebellar cognitive functions), Activities of Daily Living,<br /><br>amount of medical consumption, percentage and timing of conditioned responses<br /><br>using a delay eyeblink classical conditioning (EBCC) paradigm (motor learning),<br /><br>and cerebellar brain inhibition using transcranial magnetic stimulation (TMS).</p><br>