Ataxia, Ataxia With Oculomotor Apraxia, CANVAS, Multiple System Atrophy, Spinocerebellar Ataxia 3, Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2
Conditions
Keywords
Transcranial direct current stimulation, Transcranial magnetic stimulation, Spinocerebellar ataxia, Cerebellar ataxia
Brief summary
Neurodegenerative cerebellar ataxias represent a group of disabling disorders which currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind, sham-controlled study followed by an open-label phase, the investigators will evaluate whether a repetition of two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS, after a three months interval, may further outlast clinical improvement in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.
Detailed description
Neurodegenerative cerebellar ataxias represent a heterogeneous group of disabling disorders in which progressive ataxia of gait, limb dysmetria, oculomotor deficits, dysarthria and kinetic tremor are the prominent clinical manifestations. Both the hereditary and sporadic forms usually present in young adulthood, and are characterized by atrophy of cerebellar or brainstem structures. Currently, cerebellar ataxia lack effective disease-modifying therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. The present randomized, double-blind, sham-controlled study followed by an open-label phase will investigate a repetition of two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS, after a three months interval, may further outlast clinical improvement in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term. In addition the investigators will evaluate if tDCS intervention might improve cerebellar cognitive-affective syndrome in patients with ataxia.
Interventions
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a cerebellar syndrome and quantifiable cerebellar atrophy
Exclusion criteria
* Severe head trauma in the past * History of seizures * History of ischemic stroke or hemorrhage * Pacemaker * Metal implants in the head/neck region * Severe comorbidity * Intake of illegal drugs * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline | Baseline - 2 weeks | International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia). |
| Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline | Baseline - 2 weeks | Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia). |
| Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline | Baseline - 2 weeks | CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline | Baseline - 2 weeks - 3 month - 6 months - 9 months | Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment. |
| Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline | Baseline - 2 weeks - 3 month - 6 months - 9 months | International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia). |
| Change in the Short-Form Health Survey 36 (SF36) Score From Baseline | Baseline - 2 weeks - 3 month - 6 months - 9 months | The Italian version of the Short-Form Health Survey 36 (SF-36): consists of 36 scaled score, yielding a total score of 0 (more disability) to 100 (less disability). |
| Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline | Baseline - 2 weeks - 3 month - 6 months - 9 months | Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia). |
| Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline | Baseline - 2 weeks - 3 month - 6 months - 9 months | CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment). |
Countries
Italy
Outcome results
None listed