Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia (CStDCSAtaxia)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Completed

Conditions: Multiple System Atrophy; Spinocerebellar Ataxias; Spinocerebellar Ataxia Type 2; Spinocerebellar Degenerations; Spinocerebellar Ataxia 3; Ataxia, Spinocerebellar; Ataxia, Cerebellar; Cerebellar Ataxia; Ataxia With Oculomotor Apraxia; Friedreich Ataxia; Spinocerebellar Ataxia Type 1

Treatments: Device: Anodal cerebellar and cathodal spinal tDCS; Device: Sham cerebellar and sham spinal tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03120013

NP1576

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

Real tDCS

Experimental group

Description:

10 days anodal cerebellar and cathodal spinal tDCS

Treatment:

Device: Anodal cerebellar and cathodal spinal tDCS

Sham tDCS

Sham Comparator group

Description:

10 days sham cerebellar and sham spinal tDCS

Treatment:

Device: Sham cerebellar and sham spinal tDCS