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Reigniting the little brain: an exploratory trial of cerebellar transcranial direct current stimulation in SCA3

Reigniting the little brain: an exploratory trial of cerebellar transcranial direct current stimulation in SCA3 - An exploratory trial of cerebellar tDCS in SCA3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46775
Enrollment
20
Registered
2018-06-26
Start date
2018-10-29
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Spinocerebellar ataxia type 3

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.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * A proven SCA3 mutation (ATXN3 gene). * Age * 16 years. * SARA score * 20 (on a scale of 0 to 40).

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the absolute change on the Scale for the Assessment and Rating of Ataxia (SARA).

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)