ClinicalTrials.gg
CompletedNCT05621200SCAtACSUpdated Dec 27, 2022

Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

An interventional study of Transcranial stimulation over the cerebellar hemispheres in Ataxia, Spinocerebellar Ataxias and Multiple System Atrophy, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-27.

Primary conditionSpinocerebellar AtaxiasRegistry: AtaxiaReclassifiedWhy we changed it
Registry
Ataxia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Spinocerebellar Ataxias
Why
  1. The study's listed conditions name Spinocerebellar Ataxias, a narrower term within Ataxia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jan 2021, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Spinocerebellar Ataxias with a site in Italy — 1 open to participants now, 4 under way, 1 of them phase 3. Spinocerebellar Ataxias · Italy.

Started
2021
the only one that year
No phase
5 of 10
none open now
Registered
6th of 10
by date
Lead sponsor
3 of 10
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Among the 10 studies in Spinocerebellar Ataxias with a site in Italy, this one is the only one that started in 2021, is one of 5 with no phase, and was the 6th registered.

Spinocerebellar Ataxias

94 studies on the registry are indexed under Spinocerebellar Ataxias; 24 are open to participants now.

Browse Spinocerebellar Ataxias studies →

Open to participants now

1 of the 10 studies in Spinocerebellar Ataxias with a site in Italy is open now. Recruiting first, the newest first:

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 16 Spinocerebellar Ataxias studies recruiting now, 8 (50%) set no upper age limit and 3 (19%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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.

03

Conditions studied

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

Browse trials for

Keywords

  • transcranial direct current stimulation
  • transcranial alternate current stimulation
  • spinocerebellar ataxia
  • cerebellar ataxia
04

In context

Spinocerebellar Ataxias Reclassified

94 studies on the registry are indexed under Spinocerebellar Ataxias; 24 are open to participants now.

This study's enrollment of 26 is below the median of 31 across 60 interventional studies indexed under Spinocerebellar Ataxias.

Browse Spinocerebellar Ataxias studies →

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Compared within Spinocerebellar Ataxias, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ataxia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

Exclusion criteria

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
06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Transcranial direct current stimulation (tDCS)

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

    Device: Transcranial stimulation over the cerebellar hemispheres

  • Active comparator
    Transcranial alternate current stimulation (tDCS)

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

    Device: Transcranial stimulation over the cerebellar hemispheres

  • Sham comparator
    Placebo stimulation (sham)

    Single session of sham tDCS over the cerebellar hemispheres

    Device: Transcranial stimulation over the cerebellar hemispheres

Interventions

  • DeviceTranscranial stimulation over the cerebellar hemispheres

    Single session of Transcranial stimulation over the cerebellar hemispheres

07

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

  2. 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).

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

  2. 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.

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

  3. Change in Walking Cadence From Baseline

    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

  4. Change in 360° Turn From Baseline

    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

08

Study locations

1 site
  • ASST Spedali Civili di Brescia
    Brescia, BS 25123, Italy
09

References and documents

Publications

  • 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. PubMed 30135258 ↗
  • 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. PubMed 27838276 ↗
  • 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. PubMed 26274840 ↗
  • 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. PubMed 33950222 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Dec 2022, 22 months.

Of 28 interventional studies with no phase under Spinocerebellar Ataxias, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 22 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2022
First posted
Nov 17, 2022
StartActual
Jan 28, 2021
Primary completionActual
Dec 10, 2022
CompletionActual
Dec 10, 2022
Last update
Dec 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05621200
Lead sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Responsible party
Barbara Borroni (Professor, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia) — Principal investigator
First posted
Nov 17, 2022
Start date
Jan 28, 2021
Primary completion
Dec 10, 2022
Completion
Dec 10, 2022
Last update
Dec 27, 2022

Study contacts

Barbara Borroni, MD
principal investigator · ASST Spedali Civili di Brescia
Alberto Benussi, MD
principal investigator · Università degli Studi di Brescia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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