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

Primary Purpose

Ataxia, Cerebellar, Cerebellar Ataxia, Spinocerebellar Ataxias

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Anodal cerebellar and cathodal spinal tDCS
Sham cerebellar and sham spinal tDCS
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxia, Cerebellar focused on measuring Transcranial direct current stimulation, Transcranial magnetic stimulation, Spinocerebellar ataxia, Cerebellar ataxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AO Spedali Civili

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real tDCS

Sham tDCS

Arm Description

10 days anodal cerebellar and cathodal spinal tDCS

10 days sham cerebellar and sham spinal tDCS

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
April 14, 2017
Last Updated
March 1, 2020
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT03120013
Brief Title
Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia
Acronym
CStDCSAtaxia
Official Title
Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Transcranial direct current stimulation, Transcranial magnetic stimulation, Spinocerebellar ataxia, Cerebellar ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real tDCS
Arm Type
Experimental
Arm Description
10 days anodal cerebellar and cathodal spinal tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
10 days sham cerebellar and sham spinal tDCS
Intervention Type
Device
Intervention Name(s)
Anodal cerebellar and cathodal spinal tDCS
Intervention Description
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Intervention Type
Device
Intervention Name(s)
Sham cerebellar and sham spinal tDCS
Intervention Description
10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Primary Outcome Measure Information:
Title
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Description
International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Time Frame
Baseline - 2 weeks
Title
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
Description
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).
Time Frame
Baseline - 2 weeks
Secondary Outcome Measure Information:
Title
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Description
International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Time Frame
Baseline - 2 weeks - 1 month - 3 months
Title
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
Description
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).
Time Frame
Baseline - 2 weeks - 1 month - 3 months
Title
Change in the 9 Hole Peg Test (9HPT) Score From Baseline
Description
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.
Time Frame
Baseline - 2 weeks - 1 month - 3 months
Title
Change in the 8-Meter Walking Time (8MW) Score From Baseline
Description
4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment.
Time Frame
Baseline - 2 weeks - 1 month - 3 months
Title
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
Description
Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.
Time Frame
Baseline - 2 weeks - 1 month - 3 months
Title
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
Description
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).
Time Frame
Baseline - 2 weeks - 1 month - 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Borroni, MD
Organizational Affiliation
Azienda Ospedaliera Spedali Civili, Brescia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Benussi, MD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
AO Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26274840
Citation
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Results Reference
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Results Reference
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Results Reference
result

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Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia

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