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Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia (SCAtACS)

Primary Purpose

Ataxia, Spinocerebellar Ataxias, Multiple System Atrophy

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Transcranial stimulation over the cerebellar hemispheres

About this trial

This is an interventional treatment trial for Ataxia focused on measuring transcranial direct current stimulation, transcranial alternate current 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

ASST Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial direct current stimulation (tDCS)

Transcranial alternate current stimulation (tDCS)

Placebo stimulation (sham)

Arm Description

Single session of anodal tDCS at 2 mA over the cerebellar hemispheres

Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres

Single session of sham tDCS over the cerebellar hemispheres

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 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 Timed Up and Go Test Duration From Baseline

Time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees, assessed with gait sensors.

Change in Walking Cadence From Baseline

Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors.

Change in 360° Turn From Baseline

Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors

Full Information

NCT ID

NCT05621200

First Posted

October 20, 2022

Last Updated

December 23, 2022

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

1. Study Identification

Unique Protocol Identification Number

NCT05621200

Brief Title

Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

Acronym

SCAtACS

Official Title

Interventional Cross-over Study to Evaluate the Efficacy on Motor and Cognitive Performance of Transcranial Alternating Current Stimulation (tACS) in Patients With Neurodegenerative Ataxia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2021 (Actual)

Primary Completion Date

December 10, 2022 (Actual)

Study Completion Date

December 10, 2022 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate the effects on motor and cognitive performance of transcranial alternating current stimulation (tACS) compared to transcranial direct current stimulation (tDCS) and placebo stimulation (sham) in patients with neurodegenerative ataxia to identify a possible rehabilitation protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ataxia, Spinocerebellar Ataxias, Multiple System Atrophy, Ataxia With Oculomotor Apraxia, CANVAS

Keywords

transcranial direct current stimulation, transcranial alternate current 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

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial direct current stimulation (tDCS)

Arm Type

Active Comparator

Arm Description

Single session of anodal tDCS at 2 mA over the cerebellar hemispheres

Arm Title

Transcranial alternate current stimulation (tDCS)

Arm Type

Active Comparator

Arm Description

Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres

Arm Title

Placebo stimulation (sham)

Arm Type

Sham Comparator

Arm Description

Single session of sham tDCS over the cerebellar hemispheres

Intervention Type

Device

Intervention Name(s)

Transcranial stimulation over the cerebellar hemispheres

Intervention Description

Single session of Transcranial stimulation over the cerebellar hemispheres

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 (immediately before the intervention) - Immediately after the intervention

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 (immediately before the intervention) - Immediately after the intervention

Secondary Outcome Measure Information:

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 (immediately before the intervention) - Immediately after the intervention

Title

Change in Timed Up and Go Test Duration From Baseline

Description

Time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees, assessed with gait sensors.

Time Frame

Baseline (immediately before the intervention) - Immediately after the intervention

Title

Change in Walking Cadence From Baseline

Description

Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors.

Time Frame

Baseline (immediately before the intervention) - Immediately after the intervention

Title

Change in 360° Turn From Baseline

Description

Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors

Time Frame

Baseline (immediately before the intervention) - Immediately after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Borroni, MD

Organizational Affiliation

ASST Spedali Civili di 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

ASST Spedali Civili di Brescia

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30135258

Citation

Benussi A, Dell'Era V, Cantoni V, Bonetta E, Grasso R, Manenti R, Cotelli M, Padovani A, Borroni B. Cerebello-spinal tDCS in ataxia: A randomized, double-blind, sham-controlled, crossover trial. Neurology. 2018 Sep 18;91(12):e1090-e1101. doi: 10.1212/WNL.0000000000006210. Epub 2018 Aug 22.

Results Reference

background

PubMed Identifier

27838276

Citation

Benussi A, Dell'Era V, Cotelli MS, Turla M, Casali C, Padovani A, Borroni B. Long term clinical and neurophysiological effects of cerebellar transcranial direct current stimulation in patients with neurodegenerative ataxia. Brain Stimul. 2017 Mar-Apr;10(2):242-250. doi: 10.1016/j.brs.2016.11.001. Epub 2016 Nov 3.

Results Reference

background

PubMed Identifier

26274840

Citation

Benussi A, Koch G, Cotelli M, Padovani A, Borroni B. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study. Mov Disord. 2015 Oct;30(12):1701-5. doi: 10.1002/mds.26356. Epub 2015 Aug 14.

Results Reference

background

PubMed Identifier

33950222

Citation

Benussi A, Cantoni V, Manes M, Libri I, Dell'Era V, Datta A, Thomas C, Ferrari C, Di Fonzo A, Fancellu R, Grassi M, Brusco A, Alberici A, Borroni B. Motor and cognitive outcomes of cerebello-spinal stimulation in neurodegenerative ataxia. Brain. 2021 Sep 4;144(8):2310-2321. doi: 10.1093/brain/awab157.

Results Reference

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Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

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