AtaxiaSCAtACSNCT05621200

Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

A study testing Transcranial stimulation over the cerebellar hemispheres in people with Ataxia and Spinocerebellar Ataxias, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ataxia, Spinocerebellar Ataxias, Multiple System Atrophy
What is being tested?: Transcranial stimulation over the cerebellar hemispheres
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteItaly
Study dates: 28 Jan 2021to 10 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

ASST Spedali Civili di Brescia
Brescia, BS, 25123

Other trials in Italy

About this study

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

Conditions: Ataxia, Spinocerebellar Ataxias, Multiple System Atrophy, Ataxia With Oculomotor Apraxia, CANVAS
Being tested: Transcranial stimulation over the cerebellar hemispheres
Keywords: transcranial direct current stimulation, transcranial alternate current stimulation, spinocerebellar ataxia, cerebellar ataxia
Medical subject headings: Ataxia, Spinocerebellar Ataxias, Multiple System Atrophy, Spinocerebellar ataxia, autosomal recessive 1, Cerebellar Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial stimulation over the cerebellar hemispheresDevice
Single session of Transcranial stimulation over the cerebellar hemispheres

Study groups in NCT05621200
Study group	Role	What they receive
Transcranial direct current stimulation (tDCS)	Active comparator	Single session of anodal tDCS at 2 mA over the cerebellar hemispheres Receives: Device: Transcranial stimulation over the cerebellar hemispheres
Transcranial alternate current stimulation (tDCS)	Active comparator	Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres Receives: Device: Transcranial stimulation over the cerebellar hemispheres
Placebo stimulation (sham)	Sham comparator	Single session of sham tDCS over the cerebellar hemispheres Receives: Device: Transcranial stimulation over the cerebellar hemispheres

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline (immediately before the intervention) - Immediately after the intervention
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).
Measured: Baseline (immediately before the intervention) - Immediately after the intervention

Secondary outcomes (4)

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.
Measured: Baseline (immediately before the intervention) - Immediately after the intervention
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.
Measured: Baseline (immediately before the intervention) - Immediately after the intervention
Change in Walking Cadence From Baseline
Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors.
Measured: Baseline (immediately before the intervention) - Immediately after the intervention
Change in 360° Turn From Baseline
Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors
Measured: Baseline (immediately before the intervention) - Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 202110 Dec 2022

First posted17 Nov 2022
Study start28 Jan 2021
Primary completion10 Dec 2022
Study completion10 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for AtaxiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05621200
Sponsor's protocol ID: NP4514
Acronym: SCAtACS
Status last verified: Dec 2022
First submitted: 20 Oct 2022
Last updated: 27 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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
Libri I, Cantoni V, Benussi A, Rivolta J, Ferrari C, Fancellu R, Synofzik M, Alberici A, Padovani A, Borroni B. Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial. Cerebellum. 2024 Apr;23(2):570-578. doi: 10.1007/s12311-023-01578-6. Epub 2023 Jun 22.
PubMed 37349632

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ataxia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05621200
Acronym / sponsor ID: SCAtACS / NP4514
Conditions: Ataxia, Spinocerebellar Ataxias, Multiple System Atrophy, Ataxia With Oculomotor Apraxia, CANVAS
Keywords: transcranial direct current stimulation, transcranial alternate current stimulation, spinocerebellar ataxia, cerebellar ataxia
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
Study start: 28 Jan 2021 (actual)
Primary completion: 10 Dec 2022 (actual)
Study completion: 10 Dec 2022 (actual)
First posted: 17 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Transcranial direct current stimulation (tDCS)	Active comparator	Device: Transcranial stimulation over the cerebellar hemispheresSingle session of anodal tDCS at 2 mA over the cerebellar hemispheres
Transcranial alternate current stimulation (tDCS)	Active comparator	Device: Transcranial stimulation over the cerebellar hemispheresSingle session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres
Placebo stimulation (sham)	Sham comparator	Device: Transcranial stimulation over the cerebellar hemispheresSingle session of sham tDCS over the cerebellar hemispheres

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

Key exclusion criteria (8 listed)

Severe head trauma in the past
History of seizures
History of ischemic stroke or hemorrhage
Pacemaker
Metal implants in the head/neck region

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial stimulation over the cerebellar hemispheresSingle session of Transcranial stimulation over the cerebellar hemispheres	Device	Placebo stimulation (sham), Transcranial alternate current stimulation (tDCS), Transcranial direct current stimulation (tDCS)

Primary outcome

Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
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 (immediately before the intervention) - Immediately after the intervention
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).

4 secondary outcomes

Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Change in Timed Up and Go Test Duration From Baseline
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Change in Walking Cadence From Baseline
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Change in 360° Turn From Baseline
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
Background: PubMed 30135258Benussi 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.
Background: PubMed 27838276Benussi 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.
Background: PubMed 26274840Benussi 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.
Background: PubMed 33950222Benussi 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.
Derived from this study: PubMed 37349632Libri I, Cantoni V, Benussi A, Rivolta J, Ferrari C, Fancellu R, Synofzik M, Alberici A, Padovani A, Borroni B. Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial. Cerebellum. 2024 Apr;23(2):570-578. doi: 10.1007/s12311-023-01578-6. Epub 2023 Jun 22.
Individual participant dataSharing planned: No

Related trials for Ataxia

RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
Recruiting
Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.
Friedreich's Ataxia, Motor Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barbara Borroni, MD principal investigator

Asst Degli Spedali Civili Di Brescia

Alberto Benussi, MD principal investigator

Università degli Studi di Brescia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline (time frame: Baseline (immediately before the intervention) - Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621200, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.