Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia

Not Applicable

Completed

Conditions: Cerebellar Ataxia
Spinocerebellar Degenerations
Ataxia, Cerebellar
Spinocerebellar Ataxia Type 1
Ataxia, Spinocerebellar
Friedreich Ataxia
Ataxia With Oculomotor Apraxia
Multiple System Atrophy
Spinocerebellar Ataxias
Spinocerebellar Ataxia Type 2

Interventions: Device: Anodal cerebellar and cathodal spinal tDCS
Device: Sham cerebellar and sham spinal tDCS

Registration Number: NCT03120013

Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary: Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we 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, the investigators will evaluate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms 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 will investigate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.

Subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal cerebellar and cathodal spinal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 1 months and 3 month after treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real tDCS	Anodal cerebellar and cathodal spinal tDCS	10 days anodal cerebellar and cathodal spinal tDCS
Sham tDCS	Sham cerebellar and sham spinal tDCS	10 days sham cerebellar and sham spinal tDCS

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline	Baseline - 2 weeks - 1 month - 3 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 Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline	Baseline - 2 weeks - 1 month - 3 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 8-Meter Walking Time (8MW) Score From Baseline	Baseline - 2 weeks - 1 month - 3 months	4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment.
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline	Baseline - 2 weeks - 1 month - 3 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 9 Hole Peg Test (9HPT) Score From Baseline	Baseline - 2 weeks - 1 month - 3 months	4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment.
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline	Baseline - 2 weeks - 1 month - 3 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.