Cerebellar transcranial direct current stimulation in CCAS patients

Conditions: CCAS patients with ataxia or cerebellar stroke

Registration Number: NL-OMON28534

Lead Sponsor: Radboud University Medical Center Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Age = 16 years
-A diagnosis of degenerative cerebellar ataxia or a diagnosis of cerebellar stroke below age 50 years
-CCAS, measured as impairment on a brief neuropsychological test battery (7 tests) 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, including cerebral lesions on MRI.
-Use of neurotropic medication.
-Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Change in neuropsychological performance (a composite z-score covering relevant domains affected in CCAS, focusing on executive function and attention).

Secondary Outcome Measures

Name	Time	Method
-SARA score <br>-CCAS/Schmahmann scale <br>-EQ-5d (quality of life)<br>-POMS (mood)<br>-Possible tDCS-related side effects <br>-Percentage of patients in both conditions that correctly guess to which groups they have been randomized.<br>-Exploratory outcomes: correlations between response to intervention and relevant patient and disease-related factors (eg, age, stroke vs. degenerative disease).