An interventional study of Anodal cerebellar and cathodal spinal tDCS and Sham cerebellar and sham spinal tDCS in Ataxia, Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 1, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Treatment
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.
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.
33 studies on the registry are indexed under Machado-Joseph Disease; 5 are open to participants now.
This study's enrollment of 61 is above the median of 23 across 21 interventional studies indexed under Machado-Joseph Disease.
Browse Machado-Joseph Disease studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Compared within Machado-Joseph Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ataxia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Device: Anodal cerebellar and cathodal spinal tDCS
10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks).
Device: Anodal cerebellar and cathodal spinal tDCS · Device: Sham cerebellar and sham spinal tDCS
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)
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Time frame: Baseline - 2 weeks
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
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).
Time frame: Baseline - 2 weeks
Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline
CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment).
Time frame: Baseline - 2 weeks
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
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).
Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months
Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline
CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment).
Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.
Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
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).
Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2018 to primary completion in Dec 2020, 24 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia