AtaxiaEtABetaNCT06420271
Effects of Cerebellar tACS-iTBS in Ataxia
A study testing Real (real iTBS/tACS + exergaming) in people with Ataxia, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Ataxia
- What is being tested?
- Real (real iTBS/tACS + exergaming)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings.
- Stable medication regimen for at least four weeks prior to the study.
- Sufficient cognitive ability to understand and comply with study instructions.
Who cannot join
- History of seizures.
- Severe general impairment or concomitant diseases.
- Intracranial metal implants.
- Cardiac pacemaker.
- Pregnancy status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Santa Lucia Foundation
Rome, Lazio, 00179
0651501181
About this study
Official title: Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients
Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.
Read the detailed description
Ataxia comprises a heterogeneous group of acquired or inherited disorders primarily involving cerebellar dysfunction, leading to impaired coordination and motor learning. Traditional treatments, including medication and physical therapy, often provide limited symptomatic improvement. Non-invasive brain stimulation (NIBS) techniques have emerged as promising tools for modulating cerebellar activity and enhancing motor function. Transcranial magnetic stimulation (TMS) can influence cortical excitability and plasticity, and studies have shown that high-frequency cerebellar rTMS can improve motor performance in spinocerebellar ataxia. Intermittent theta burst stimulation (iTBS), a patterned form of TMS, has demonstrated benefits in other movement disorders, suggesting potential applicability to ataxia. Transcranial direct current stimulation (tDCS), which modulates neuronal excitability via weak electrical currents, has shown improvements in static and dynamic balance in degenerative cerebellar ataxia. Transcranial alternating current stimulation (tACS) modulates neural oscillations and early studies indicate possible benefits for ataxia symptoms. Recent work has explored combining NIBS modalities to enhance neuromodulatory effects. In preliminary experiments, combined cerebellar tACS and iTBS increased MEP amplitudes more than iTBS alone, with effects lasting up to 30 minutes. These synergistic effects may translate into improved motor performance, coordination, and balance. The present study aims to investigate whether combining real or sham tACS with iTBS produces greater benefits than exergaming biofeedback alone in individuals with ataxia. A cross-over design will be used so that each participant serves as their own control. The primary outcomes will include motor coordination, balance, and cerebello-cortical plasticity. The rationale is that tACS may optimize oscillatory activity while iTBS enhances excitability, thereby jointly promoting neuroplasticity in cerebellar networks. The study will recruit individuals diagnosed with ataxia and assess the therapeutic potential of combined NIBS interventions.
- Conditions
- Ataxia
- Being tested
- Real (real iTBS/tACS + exergaming), Sham (sham iTBS/tACS + exergaming)
- Keywords
- Non Invasive Brain Stimulation, Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation, Transcranial Electrical Stimulation, Transcranial Alternating Current Stimulation, Exergaming
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real (real iTBS/tACS + exergaming)Device
Also called real iTBS/tACS + exergaming
Stimulation will be applied to the cerebellum. The tACS session duration will be 190 seconds with a frequency of 5 Hz coupled with iTBS (coil positioned tangentially with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading).
Sham (sham iTBS/tACS + exergaming)Device
Also called sham iTBS/tACS + exergaming
Stimulation will be applied to the cerebellum. The tACS session duration will be 10 seconds with a frequency of 5 Hz coupled with sham iTBS (coil positioned perpendicularly with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading).
| Study group | Role | What they receive |
|---|---|---|
| Real tACS + real iTBS + exergaming | Experimental | 10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks. Receives: Device: Real (real iTBS/tACS + exergaming) |
| Sham tACS + sham iTBS + exergaming | Placebo comparator | 10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks. Receives: Device: Sham (sham iTBS/tACS + exergaming) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the International Cooperative Ataxia Rating Scale (ICARS)
ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Score ranges from 0 to 100 where 100 indicates severe ataxia.
Measured: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Secondary outcomes (4)
Changes in the Short Form-36 Health Survey (SF-36)
SF-36 is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Scores range from 0 to 100 for each domain, where 100 indicates a more favorable health-state.
Measured: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Changes in postural control
Instrumented postural stability will be assessed using a 75 cm (length x width) static force platform (PlatformBPM 120, Physical Support Italia, Italy). The signals will be amplified and acquired using dedicated software (Physical Gait Software Vv. 2.66, Physical SupportItalia, Italy). The length of the center of pressure (CoP) trajectory (mm) will be measured as indicator of the postural stability. An increase in the length of CoP indicates a severe impairment in postural control.
Measured: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Changes in cortico-spinal excitability
Twenty Motor evoked potentials (MEPs) will be collected from left and right primary motor cortex with single pulses of transcranial magnetic stimulation (TMS) set at 1 mV. An increase in the MEPs amplitude indicates an improvement in cortico-spinal activity recorded from the first dorsal interosseous and tibialis anterior muscles.
Measured: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Change in the Scale for the Assessment and Rating of Ataxia (SARA)
SARA is a clinical scale developed to assess a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. Score ranges from 0 to 40 where 40 indicates severe ataxia.
Measured: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Model description
- A randomized cross-over design will be used. A 3-weeks wash-out period will be observed between the two conditions (real and sham).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny Spampinato, PhD, Study chair, University of Roma La SapienzaAlex Martino Cinnera, PhD, Study chair, IRCCS Santa Lucia Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420271
- Sponsor's protocol ID
- 80/SL/23
- Acronym
- EtABeta
- Status last verified
- Sep 2025
- First submitted
- 14 May 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spampinato D, Avci E, Rothwell J, Rocchi L. Frequency-dependent modulation of cerebellar excitability during the application of non-invasive alternating current stimulation. Brain Stimul. 2021 Mar-Apr;14(2):277-283. doi: 10.1016/j.brs.2021.01.007. Epub 2021 Jan 20.
PubMed 33482375Libri 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 37349632Guerra A, Suppa A, Bologna M, D'Onofrio V, Bianchini E, Brown P, Di Lazzaro V, Berardelli A. Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation. Brain Stimul. 2018 Jul-Aug;11(4):734-742. doi: 10.1016/j.brs.2018.03.015. Epub 2018 Mar 24.
PubMed 29615367Gong C, Long Y, Peng XM, Hu H, Chen J, Xiao L, Zhong YB, Wang MY, Luo Y. Efficacy and safety of noninvasive brain stimulation for patients with cerebellar ataxia: a systematic review and meta-analysis of randomized controlled trials. J Neurol. 2023 Oct;270(10):4782-4799. doi: 10.1007/s00415-023-11799-8. Epub 2023 Jul 17.
PubMed 37460852Spampinato DA, Pezzopane V, Cinnera AM, D'Arienzo M, Piatti D, Ferraresi M, Vinci AC, Colona VL, Vasco G, Grasso MG, Paolucci S, Bonni S, Koch G. Effects of combined cerebellar tACS-iTBS in individuals with ataxia (EtABeta): a crossover investigation. Trials. 2026 Mar 24;27(1):346. doi: 10.1186/s13063-026-09653-z.
PubMed 41877266
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients
- ClinicalTrials.gov ID
- NCT06420271
- Acronym / sponsor ID
- EtABeta / 80/SL/23
- Conditions
- Ataxia
- Keywords
- Non Invasive Brain Stimulation, Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation, Transcranial Electrical Stimulation, Transcranial Alternating Current Stimulation, Exergaming
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2024 (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.
Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.
Detailed description
Ataxia comprises a heterogeneous group of acquired or inherited disorders primarily involving cerebellar dysfunction, leading to impaired coordination and motor learning. Traditional treatments, including medication and physical therapy, often provide limited symptomatic improvement. Non-invasive brain stimulation (NIBS) techniques have emerged as promising tools for modulating cerebellar activity and enhancing motor function. Transcranial magnetic stimulation (TMS) can influence cortical excitability and plasticity, and studies have shown that high-frequency cerebellar rTMS can improve motor performance in spinocerebellar ataxia. Intermittent theta burst stimulation (iTBS), a patterned form of TMS, has demonstrated benefits in other movement disorders, suggesting potential applicability to ataxia. Transcranial direct current stimulation (tDCS), which modulates neuronal excitability via weak electrical currents, has shown improvements in static and dynamic balance in degenerative cerebellar ataxia. Transcranial alternating current stimulation (tACS) modulates neural oscillations and early studies indicate possible benefits for ataxia symptoms. Recent work has explored combining NIBS modalities to enhance neuromodulatory effects. In preliminary experiments, combined cerebellar tACS and iTBS increased MEP amplitudes more than iTBS alone, with effects lasting up to 30 minutes. These synergistic effects may translate into improved motor performance, coordination, and balance. The present study aims to investigate whether combining real or sham tACS with iTBS produces greater benefits than exergaming biofeedback alone in individuals with ataxia. A cross-over design will be used so that each participant serves as their own control. The primary outcomes will include motor coordination, balance, and cerebello-cortical plasticity. The rationale is that tACS may optimize oscillatory activity while iTBS enhances excitability, thereby jointly promoting neuroplasticity in cerebellar networks. The study will recruit individuals diagnosed with ataxia and assess the therapeutic potential of combined NIBS interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized cross-over design will be used. A 3-weeks wash-out period will be observed between the two conditions (real and sham).
| Arm | Type | Receives |
|---|---|---|
| Real tACS + real iTBS + exergaming | Experimental | Device: Real (real iTBS/tACS + exergaming)10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks. |
| Sham tACS + sham iTBS + exergaming | Placebo comparator | Device: Sham (sham iTBS/tACS + exergaming)10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings.
- Stable medication regimen for at least four weeks prior to the study.
- Sufficient cognitive ability to understand and comply with study instructions.
Key exclusion criteria (5 listed)
- History of seizures.
- Severe general impairment or concomitant diseases.
- Intracranial metal implants.
- Cardiac pacemaker.
- Pregnancy status.
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 |
|---|---|---|
| Real (real iTBS/tACS + exergaming)Also: real iTBS/tACS + exergamingStimulation will be applied to the cerebellum. The tACS session duration will be 190 seconds with a frequency of 5 Hz coupled with iTBS (coil positioned tangentially with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading). | Device | Real tACS + real iTBS + exergaming |
| Sham (sham iTBS/tACS + exergaming)Also: sham iTBS/tACS + exergamingStimulation will be applied to the cerebellum. The tACS session duration will be 10 seconds with a frequency of 5 Hz coupled with sham iTBS (coil positioned perpendicularly with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading). | Device | Sham tACS + sham iTBS + exergaming |
Primary outcome
Changes in the International Cooperative Ataxia Rating Scale (ICARS)
Time frame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Score ranges from 0 to 100 where 100 indicates severe ataxia.
4 secondary outcomes
Changes in the Short Form-36 Health Survey (SF-36)
Time frame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Changes in postural control
Time frame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Changes in cortico-spinal excitability
Time frame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Change in the Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 33482375Spampinato D, Avci E, Rothwell J, Rocchi L. Frequency-dependent modulation of cerebellar excitability during the application of non-invasive alternating current stimulation. Brain Stimul. 2021 Mar-Apr;14(2):277-283. doi: 10.1016/j.brs.2021.01.007. Epub 2021 Jan 20.
- Background: 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.
- Background: PubMed 29615367Guerra A, Suppa A, Bologna M, D'Onofrio V, Bianchini E, Brown P, Di Lazzaro V, Berardelli A. Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation. Brain Stimul. 2018 Jul-Aug;11(4):734-742. doi: 10.1016/j.brs.2018.03.015. Epub 2018 Mar 24.
- Background: PubMed 37460852Gong C, Long Y, Peng XM, Hu H, Chen J, Xiao L, Zhong YB, Wang MY, Luo Y. Efficacy and safety of noninvasive brain stimulation for patients with cerebellar ataxia: a systematic review and meta-analysis of randomized controlled trials. J Neurol. 2023 Oct;270(10):4782-4799. doi: 10.1007/s00415-023-11799-8. Epub 2023 Jul 17.
- Derived from this study: PubMed 41877266Spampinato DA, Pezzopane V, Cinnera AM, D'Arienzo M, Piatti D, Ferraresi M, Vinci AC, Colona VL, Vasco G, Grasso MG, Paolucci S, Bonni S, Koch G. Effects of combined cerebellar tACS-iTBS in individuals with ataxia (EtABeta): a crossover investigation. Trials. 2026 Mar 24;27(1):346. doi: 10.1186/s13063-026-09653-z.
- Individual participant dataSharing planned: No
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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.
Danny Spampinato, PhD study chair
University of Roma La Sapienza
Alex Martino Cinnera, PhD study chair
IRCCS Santa Lucia Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real (real iTBS/tACS + exergaming) in people with Ataxia, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Koch, Prof. (0651501181, g.koch@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the International Cooperative Ataxia Rating Scale (ICARS) (time frame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)). 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 NCT06420271, 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 17 Feb 2026.