Clinical trial NCT04153110: Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia
Official title: Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxias: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia
Spinocerebellar Ataxias
Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia 3
Multiple System Atrophy
Ataxia With Oculomotor Apraxia
CANVAS
Keywords: Transcranial direct current stimulation
Transcranial magnetic stimulation
Spinocerebellar ataxia
Cerebellar ataxia
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
timeFrame: Baseline - 2 weeks
measure: Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
timeFrame: Baseline - 2 weeks
measure: Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline
timeFrame: Baseline - 2 weeks
Secondary outcomes:
measure: Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
timeFrame: Baseline - 2 weeks - 3 month - 6 months - 9 months
measure: Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
timeFrame: Baseline - 2 weeks - 3 month - 6 months - 9 months
measure: Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline
timeFrame: Baseline - 2 weeks - 3 month - 6 months - 9 months
measure: Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
timeFrame: Baseline - 2 weeks - 3 month - 6 months - 9 months
measure: Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
timeFrame: Baseline - 2 weeks - 3 month - 6 months - 9 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: AO Spedali Civili
state: BS
Study officials:
affiliation: Azienda Ospedaliera Spedali Civili, Brescia
name: Barbara Borroni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Brescia
name: Alberto Benussi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benussi A, Dell'Era V, Cantoni V, Bonetta E, Grasso R, Manenti R, Cotelli M, Padovani A, Borroni B. Cerebello-spinal tDCS in ataxia: A randomized, double-blind, sham-controlled, crossover trial. Neurology. 2018 Sep 18;91(12):e1090-e1101. doi: 10.1212/WNL.0000000000006210. Epub 2018 Aug 22.
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