Clinical trial NCT03120013: Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia
Official title: Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia, Cerebellar
Cerebellar Ataxia
Spinocerebellar Ataxias
Ataxia, Spinocerebellar
Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia 3
Spinocerebellar Degenerations
Friedreich Ataxia
Ataxia With Oculomotor Apraxia
Multiple System Atrophy
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: 2017-04-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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
Secondary outcomes:
measure: Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
timeFrame: Baseline - 2 weeks - 1 month - 3 months
measure: Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
timeFrame: Baseline - 2 weeks - 1 month - 3 months
measure: Change in the 9 Hole Peg Test (9HPT) Score From Baseline
timeFrame: Baseline - 2 weeks - 1 month - 3 months
measure: Change in the 8-Meter Walking Time (8MW) Score From Baseline
timeFrame: Baseline - 2 weeks - 1 month - 3 months
measure: Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
timeFrame: Baseline - 2 weeks - 1 month - 3 months
measure: Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
timeFrame: Baseline - 2 weeks - 1 month - 3 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, Koch G, Cotelli M, Padovani A, Borroni B. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study. Mov Disord. 2015 Oct;30(12):1701-5. doi: 10.1002/mds.26356. Epub 2015 Aug 14.
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