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

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ClinicalTrials.gov Identifier: NCT03120013
Recruitment Status : Completed
First Posted : April 19, 2017
Results First Posted : June 28, 2019
Last Update Posted : June 28, 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 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.

Condition or disease Intervention/treatment Phase
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 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 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018


Arm Intervention/treatment
Experimental: Real tDCS
10 days anodal cerebellar and cathodal spinal tDCS
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
10 days sham cerebellar and sham spinal tDCS
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).


Secondary Outcome Measures :
  1. Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 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 - 1 month - 3 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 9 Hole Peg Test (9HPT) Score From Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
    4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment.

  4. Change in the 8-Meter Walking Time (8MW) Score From Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
    4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment.

  5. Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 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.

  6. Change in the Short-Form Health Survey 36 (SF36) Score From Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 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): NCT03120013


Locations
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Italy
AO Spedali Civili
Brescia, BS, Italy, 25100
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 of Results:
Other Publications:

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Responsible Party: Barbara Borroni, Professor, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03120013     History of Changes
Other Study ID Numbers: NP1576
First Posted: April 19, 2017    Key Record Dates
Results First Posted: June 28, 2019
Last Update Posted: June 28, 2019
Last Verified: April 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
Product Manufactured in and Exported from the U.S.: 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
Friedreich Ataxia
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
Mitochondrial Diseases
Metabolic Diseases