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Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia (SCA02)

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ClinicalTrials.gov Identifier: NCT04153110
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia

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.

Condition or disease Intervention/treatment Phase
Ataxia Spinocerebellar Ataxias Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia 3 Multiple System Atrophy Ataxia With Oculomotor Apraxia CANVAS Device: Anodal cerebellar and cathodal spinal tDCS Device: Sham cerebellar and sham spinal tDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxias: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Experimental: Real tDCS - Real tDCS
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Device: Anodal cerebellar and cathodal spinal tDCS
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Sham Comparator: Sham tDCS - Real tDCS
10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks).
Device: Anodal cerebellar and cathodal spinal tDCS
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153110


Contacts
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Contact: Barbara Borroni, MD +39 030 3995631 barbara.borroni@unibs.it

Locations
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Italy
AO Spedali Civili Recruiting
Brescia, BS, Italy, 25100
Contact: Barbara Borroni, MD    00390303995632    bborroni@inwind.it   
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
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Principal Investigator: Barbara Borroni, MD Azienda Ospedaliera Spedali Civili, Brescia
  Study Documents (Full-Text)

Documents provided by Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia:

Publications:

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Responsible Party: Barbara Borroni, Professor, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT04153110     History of Changes
Other Study ID Numbers: NP3244
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia:
Transcranial direct current stimulation
Transcranial magnetic stimulation
Spinocerebellar ataxia
Cerebellar ataxia
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Multiple System Atrophy
Shy-Drager Syndrome
Apraxias
Machado-Joseph Disease
Cogan Syndrome
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Primary Dysautonomias
Autonomic Nervous System Diseases
Basal Ganglia Diseases
Movement Disorders
Hypotension
Vascular Diseases
Cardiovascular Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Vestibulocochlear Nerve Diseases