Treating big problems arising from the little brain: A double-blind, sham-controlled, exploratory trial to investigate the effect of cerebellar anodal transcranial direct current stimulation in patient with CCAS

Treating big problems arising from the little brain: A double-blind, sham-controlled, exploratory trial to investigate the effect of cerebellar anodal transcranial direct current stimulation in patient with CCAS - An exploratory trial of cerebellar tDCS in CCAS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52902

Enrollment

Registered

2020-09-02

Start date

2021-06-07

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CCAS cerebellar cognitive affective syndrome

Interventions

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.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• 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)	—

Measure

Time frame

• 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)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026