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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 : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Barbara Borroni, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 19, 2017
Results First Submitted Date  ICMJE May 23, 2018
Results First Posted Date  ICMJE June 28, 2019
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE February 6, 2017
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • Change in the ICARS score from baseline [ Time Frame: Baseline - 2 weeks ]
    Change in the International Cooperative Ataxia Rating Scale (ICARS) score from baseline
  • Change in the SARA score from baseline [ Time Frame: Baseline - 2 weeks ]
    Change in the Scale for the Assessment and Rating of Ataxia (SARA) score from baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • Change in the ICARS score from baseline [ Time Frame: Baseline - 1 month - 3 months ]
    Change in the International Cooperative Ataxia Rating Scale (ICARS) score from baseline
  • Change in the SARA score from baseline [ Time Frame: Baseline - 1 month - 3 months ]
    Change in the Scale for the Assessment and Rating of Ataxia (SARA) score from baseline
  • Change in the 9HPT score from baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
    Change in the Nine Hole Peg Test (9HPT) score (4 trials for each hand) from baseline
  • Change in the 8MWT score from baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
    Change in the 8-Meter Walking Time score (4 trials) from baseline
  • Change in CBI measurements from Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on cerebellar brain inhibition (CBI)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia
Official Title  ICMJE Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: Real tDCS
    10 days anodal cerebellar and cathodal spinal tDCS
    Intervention: Device: Anodal cerebellar and cathodal spinal tDCS
  • Sham Comparator: Sham tDCS
    10 days sham cerebellar and sham spinal tDCS
    Intervention: Device: Sham cerebellar and sham spinal tDCS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
30
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120013
Other Study ID Numbers  ICMJE NP1576
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbara Borroni, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Sponsor  ICMJE Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Borroni, MD Azienda Ospedaliera Spedali Civili, Brescia
Principal Investigator: Alberto Benussi, MD Università degli Studi di Brescia
PRS Account Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP