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NCT Number: NCT04153110

Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia

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.

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Key information

Conditions

Ataxia Ataxia With Oculomotor Apraxia Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases CANVAS Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Machado-Joseph Disease Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Spinal Cord Diseases Spinocerebellar Ataxia 3 Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxias Spinocerebellar Degenerations Spinocerebellar ataxia, autosomal recessive 1 Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AO Spedali Civili

Brescia, BS, 25100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal cerebellar and cathodal spinal tDCS

Device

10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Sham cerebellar and sham spinal tDCS

Device

10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Primary outcomes

  1. 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).

  2. 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).

  3. 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

  1. Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline

    Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months

    International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).

  2. Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline

    Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months

    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).

  3. Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline

    Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months

    CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment).

  4. Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline

    Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months

    Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.

  5. Change in the Short-Form Health Survey 36 (SF36) Score From Baseline

    Time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months

    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).

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxias: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase

Acronym: SCA02

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 6, 2019
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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