Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxias: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ataxia
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Barbara Borroni
Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change in the Short-Form Health Survey 36 (SF36) Score From Baseline(Baseline - 2 weeks - 3 month - 6 months - 9 months)
- Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline(Baseline - 2 weeks - 3 month - 6 months - 9 months)
- Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline(Baseline - 2 weeks - 3 month - 6 months - 9 months)
- Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline(Baseline - 2 weeks - 3 month - 6 months - 9 months)
- Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline(Baseline - 2 weeks - 3 month - 6 months - 9 months)