Ataxia, CerebellarNCT07250321
Efficacy of tDCS in Degenerative Ataxia
A study testing transcranial direct current stimulation in people with Ataxia, Cerebellar and Ataxia - Genetic Diagnosis - Unknown, run by University of Cagliari at 1 site in Italy.
Trial summary
Degenerative cerebellar ataxias are a group of rare diseases that cause gradual damage to the cerebellum, the part of the brain that controls balance and coordination. People with these conditions may have difficulty walking, keeping their balance, or coordinating movements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ataxia, Cerebellar, Ataxia - Genetic Diagnosis - Unknown, Ataxia, Spinocerebellar
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2023to Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical, radiological and/or genetic diagnosis of cerebellar ataxia
Who cannot join
- presence of electrical stimulators (i.e., pacemaker), pregnancy, visual disfunction, cognitive decline, mild to moderate ataxic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-controlled Clinical and Quantitative Analysis.
Degenerative cerebellar ataxias are a group of rare diseases that cause gradual damage to the cerebellum, the part of the brain that controls balance and coordination. People with these conditions may have difficulty walking, keeping their balance, or coordinating movements. They may also experience vision problems, muscle stiffness, tremors, or changes in behavior, depending on the specific cause of the disease.
These disorders can greatly affect independence and quality of life, and unfortunately, there are currently no treatments that can stop or reverse the disease. Most care focuses on managing symptoms with physical therapy and medication.
Read more
Recently, a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) has been studied as a possible way to improve movement and thinking in people with ataxia. However, results so far have been mixed, possibly because of differences in disease type, treatment methods, and how improvements are measured.
New technologies, such as motion sensors and movement analysis, are helping researchers better measure the effects of treatments on walking, balance, and hand movements in daily life.
The goal of the current study is to test whether stimulating the cerebellum with anodal tDCS can improve movement in people with different types of degenerative ataxia. The study will use both standard clinical scales and precise movement analysis to measure changes. In addition, researchers will use brain recordings (EEG) taken before and after stimulation to better understand how tDCS may work in the brain
Read the detailed description
Degenerative cerebellar ataxias are a heterogeneous group of inherited and acquired disorders characterized by cerebellar atrophy and degeneration which leads to a wide range of clinical symptoms. Indeed, beside cerebellar symptoms such as gait ataxia, postural unbalance, dysmetria and nystagmus, patients may exhibit peripheral neuropathy, pyramidal and extrapyramidal signs and behavioural symptoms, depending on the aetiology of the disorder.
These disorders substantially affect autonomy and quality of life, yet effective disease-modifying or symptomatic treatments remain limited; their current management is largely supportive, including physical therapy and symptomatic pharmacological interventions.
Among non-pharmacological treatments, cerebellar transcranial direct current stimulation (tDCS), a non-invasive brain stimulation (NIBS) technique, has been employed in several studies with the aim to improve both motor and cognitive symptoms in different forms of ataxia, with conflicting results, so that, at present, it is not possible to determine its therapeutic potential with certainty. In this regard, it has been hypothesized that the large variability of clinical outcomes associated with such approach is due to several factors including, among the most relevant, the heterogeneity of ataxia aetiology, the significant differences in terms of protocols of stimulation and the lack of sensitive objective measures to be integrated with the scales traditionally employed in the clinical routine. Indeed, in the last years, quantitative analysis of movement (performed using either motion capture system or wearable inertial sensors) has shown to be a reliable approach to assess, in combination with clinical data, the existence and magnitude of possible positive effects induced by NIBS on basic motor functions (i.e., gait and balance) as well as to monitor real-world mobility and characterize physical activity patterns of people with ataxia.
The ability of cerebellar tDCS to influence the cerebellar-thalamus-cortical pathway has been demonstrated by the cerebellar-brain inhibition (CBI) TMS paradigm. Moreover, the cerebellar-cortical connectivity has been explored with NIBS combined with functional magnetic resonance imaging (fMRI) and EEG with online and offline paradigms. Several studies show that cerebellar NIBS is able to influence cortical oscillations and that an increase of beta power in frontal and parietal region is involved sensory-motor integration and motor control through the modulation of the cerebellar-thalums cortical circuit; the role of cortical gamma oscillation on motor activity following cerebellar stimulation is less characterized, but some evidence indicates that cortical gamma activity reflects excitatory action of the cerebellum on the motor thalamus and the motor cortex. However, in this case the results are controversial probably due to the heterogeneous methodological approaches.
Based on these observations, the aim of the present study was to assess the efficacy of cerebellar anodal tDCS in improving ataxia in different forms of degenerative ataxia with a sham-controlled approach, using validated clinical rating scales as well as quantitative techniques for human movement analysis focused on gait and upper limb functionality (i.e., hand-to-mouth task) as data on these motor tasks are already available for people with ataxia.
Moreover, in order to explore the mechanism underlying the therapeutic effect of cerebellar tDCS data obtained from resting state EEG before and after stimulation will be analyzed.
- Conditions
- Ataxia, Cerebellar, Ataxia - Genetic Diagnosis - Unknown, Ataxia, Spinocerebellar, Ataxias, Hereditary
- Being tested
- transcranial direct current stimulation, Sham (No Treatment)
- Keywords
- ataxia, tDCS, non-invasive brain stimulation, gait, upper limb, quantitative analysis
- Medical subject headings
- Cerebellar Ataxia, Spinocerebellar Ataxias, Spinocerebellar Degenerations, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called Real
Anodal stimulation is delivered by a battery-driven stimulator (NeuroConn GmbH, 98693 Ilmenau, Germany) through a pair of saline-soaked surface sponge electrodes (7 x 5 cm2) producing a constant current of 2 mA for 20 min. An electroconductive gel is applied to the electrodes to reduce contact impedance and the electrodes are held in place using elastic gauzes Stimulation is preceded by a ramping up and ramping down for 20 sec at the beginning and at the end of each session, respectively. The anode is placed 2 cm under the inion and the cathode was placed over the right deltoid muscle. For sham stimulation the machine did not deliver any current after the ramping up, so both groups of patients could feel the same skin sensation.
Sham (No Treatment)Device
Also called Sham
In the "Sham" arm, no current was delivered to the brain except for the initial few seconds
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | For sham stimulation the tDCS device delivered just a short ramp of current to let patients feel a skin sensation similar to those perceived by those actually treated. Receives: Device: Sham (No Treatment) |
| Real | Active comparator | Not described Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified International Cooperative Ataxia Rating Scale (MICARS)
The Modified International Cooperative Ataxia Rating Scale (MICARS) is a clinical tool used to assess and quantify the severity of ataxia, a neurological condition characterized by impaired coordination and balance. It is a streamlined version of the original International Cooperative Ataxia Rating Scale (ICARS), designed to improve ease of use, reliability, and sensitivity to clinical changes. MICARS evaluates key domains such as gait and posture, limb coordination, speech, and eye movements, providing a numerical score that reflects overall ataxia severity. It is commonly used in both clinical practice and research to monitor disease progression and treatment effects in patients with cerebellar ataxia and related disorders.
Measured: Before the first tDCS session (T0) and after 10 sessions (2 weeks)
Secondary outcomes (2)
Scale for the Assessment and Rating of Ataxia (SARA)
The Scale for the Assessment and Rating of Ataxia (SARA) is a standardized clinical tool used to evaluate the severity and progression of ataxia. It consists of eight performance-based items that assess functions such as gait, stance, sitting, speech, and limb coordination (including finger-chase, nose-finger test, fast alternating hand movements, and heel-shin slide). Each item is scored on a defined scale, and the total score ranges from 0 (no ataxia) to 40 (most severe ataxia). SARA is valued for its simplicity, reliability, and sensitivity to change, making it widely used in both clinical trials and routine neurological assessments of cerebellar disorders.
Measured: Before the first tDCS session (T0) and after 2 weeks (10 sessions)
Robertson Dysarthria profile
The Robertson Dysarthria Profile is a comprehensive clinical assessment tool used to evaluate and document speech difficulties associated with dysarthria, a motor speech disorder caused by neurological impairment. It examines key aspects of speech production, including respiration, phonation, articulation, resonance, and prosody, as well as the patient's intelligibility and communication effectiveness. The profile helps clinicians identify the type and severity of dysarthria, monitor changes over time, and plan targeted therapy. It is particularly useful in both diagnostic assessment and treatment planning for individuals with acquired or developmental speech motor disorders.
Measured: Befofe the first tDCS session and after 2 weeks (10 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start9 Oct 2023
- Primary completion21 Jul 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ataxia, CerebellarStudies 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
- Parallel groups
- Model description
- Sham-controlled study
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Pau, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250321
- Sponsor's protocol ID
- 4642022/CE Study Code tDCS-ATX
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) that will be collected throughout the trial will include all de-identified data relevant to the study's primary and secondary outcomes as well as demographic and clinical characteristics
Publications
Sanna A, Pau M, Porta M, Pilia G, Secci V, Cartella E, Demattia A, Paribello A, Cossu G, Milia A, Tacconi P. Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-Controlled Clinical and Quantitative Analysis. Cerebellum. 2026 Jan 14;25(1):11. doi: 10.1007/s12311-025-01952-6.
PubMed 41533249
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-controlled Clinical and Quantitative Analysis.
- ClinicalTrials.gov ID
- NCT07250321
- Acronym / sponsor ID
- 4642022/CE Study Code tDCS-ATX
- Conditions
- Ataxia, Cerebellar, Ataxia - Genetic Diagnosis - Unknown, Ataxia, Spinocerebellar, Ataxias, Hereditary
- Keywords
- ataxia, tDCS, non-invasive brain stimulation, gait, upper limb, quantitative analysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Nov 2025 (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.
Degenerative cerebellar ataxias are a group of rare diseases that cause gradual damage to the cerebellum, the part of the brain that controls balance and coordination. People with these conditions may have difficulty walking, keeping their balance, or coordinating movements. They may also experience vision problems, muscle stiffness, tremors, or changes in behavior, depending on the specific cause of the disease.
These disorders can greatly affect independence and quality of life, and unfortunately, there are currently no treatments that can stop or reverse the disease. Most care focuses on managing symptoms with physical therapy and medication.
Recently, a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) has been studied as a possible way to improve movement and thinking in people with ataxia. However, results so far have been mixed, possibly because of differences in disease type, treatment methods, and how improvements are measured.
New technologies, such as motion sensors and movement analysis, are helping researchers better measure the effects of treatments on walking, balance, and hand movements in daily life.
The goal of the current study is to test whether stimulating the cerebellum with anodal tDCS can improve movement in people with different types of degenerative ataxia. The study will use both standard clinical scales and precise movement analysis to measure changes. In addition, researchers will use brain recordings (EEG) taken before and after stimulation to better understand how tDCS may work in the brain
Detailed description
Degenerative cerebellar ataxias are a heterogeneous group of inherited and acquired disorders characterized by cerebellar atrophy and degeneration which leads to a wide range of clinical symptoms. Indeed, beside cerebellar symptoms such as gait ataxia, postural unbalance, dysmetria and nystagmus, patients may exhibit peripheral neuropathy, pyramidal and extrapyramidal signs and behavioural symptoms, depending on the aetiology of the disorder.
These disorders substantially affect autonomy and quality of life, yet effective disease-modifying or symptomatic treatments remain limited; their current management is largely supportive, including physical therapy and symptomatic pharmacological interventions.
Among non-pharmacological treatments, cerebellar transcranial direct current stimulation (tDCS), a non-invasive brain stimulation (NIBS) technique, has been employed in several studies with the aim to improve both motor and cognitive symptoms in different forms of ataxia, with conflicting results, so that, at present, it is not possible to determine its therapeutic potential with certainty. In this regard, it has been hypothesized that the large variability of clinical outcomes associated with such approach is due to several factors including, among the most relevant, the heterogeneity of ataxia aetiology, the significant differences in terms of protocols of stimulation and the lack of sensitive objective measures to be integrated with the scales traditionally employed in the clinical routine. Indeed, in the last years, quantitative analysis of movement (performed using either motion capture system or wearable inertial sensors) has shown to be a reliable approach to assess, in combination with clinical data, the existence and magnitude of possible positive effects induced by NIBS on basic motor functions (i.e., gait and balance) as well as to monitor real-world mobility and characterize physical activity patterns of people with ataxia.
The ability of cerebellar tDCS to influence the cerebellar-thalamus-cortical pathway has been demonstrated by the cerebellar-brain inhibition (CBI) TMS paradigm. Moreover, the cerebellar-cortical connectivity has been explored with NIBS combined with functional magnetic resonance imaging (fMRI) and EEG with online and offline paradigms. Several studies show that cerebellar NIBS is able to influence cortical oscillations and that an increase of beta power in frontal and parietal region is involved sensory-motor integration and motor control through the modulation of the cerebellar-thalums cortical circuit; the role of cortical gamma oscillation on motor activity following cerebellar stimulation is less characterized, but some evidence indicates that cortical gamma activity reflects excitatory action of the cerebellum on the motor thalamus and the motor cortex. However, in this case the results are controversial probably due to the heterogeneous methodological approaches.
Based on these observations, the aim of the present study was to assess the efficacy of cerebellar anodal tDCS in improving ataxia in different forms of degenerative ataxia with a sham-controlled approach, using validated clinical rating scales as well as quantitative techniques for human movement analysis focused on gait and upper limb functionality (i.e., hand-to-mouth task) as data on these motor tasks are already available for people with ataxia.
Moreover, in order to explore the mechanism underlying the therapeutic effect of cerebellar tDCS data obtained from resting state EEG before and after stimulation will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sham-controlled study
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham (No Treatment)For sham stimulation the tDCS device delivered just a short ramp of current to let patients feel a skin sensation similar to those perceived by those actually treated. |
| Real | Active comparator | Device: transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical, radiological and/or genetic diagnosis of cerebellar ataxia
Key exclusion criteria (1 listed)
- presence of electrical stimulators (i.e., pacemaker), pregnancy, visual disfunction, cognitive decline, mild to moderate ataxic symptoms
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 direct current stimulationAlso: RealAnodal stimulation is delivered by a battery-driven stimulator (NeuroConn GmbH, 98693 Ilmenau, Germany) through a pair of saline-soaked surface sponge electrodes (7 x 5 cm2) producing a constant current of 2 mA for 20 min. An electroconductive gel is applied to the electrodes to reduce contact impedance and the electrodes are held in place using elastic gauzes Stimulation is preceded by a ramping up and ramping down for 20 sec at the beginning and at the end of each session, respectively. The anode is placed 2 cm under the inion and the cathode was placed over the right deltoid muscle. For sham stimulation the machine did not deliver any current after the ramping up, so both groups of patients could feel the same skin sensation. | Device | Real |
| Sham (No Treatment)Also: ShamIn the "Sham" arm, no current was delivered to the brain except for the initial few seconds | Device | Sham |
Primary outcome
Modified International Cooperative Ataxia Rating Scale (MICARS)
Time frame: Before the first tDCS session (T0) and after 10 sessions (2 weeks)
The Modified International Cooperative Ataxia Rating Scale (MICARS) is a clinical tool used to assess and quantify the severity of ataxia, a neurological condition characterized by impaired coordination and balance. It is a streamlined version of the original International Cooperative Ataxia Rating Scale (ICARS), designed to improve ease of use, reliability, and sensitivity to clinical changes. MICARS evaluates key domains such as gait and posture, limb coordination, speech, and eye movements, providing a numerical score that reflects overall ataxia severity. It is commonly used in both clinical practice and research to monitor disease progression and treatment effects in patients with cerebellar ataxia and related disorders.
2 secondary outcomes
Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: Before the first tDCS session (T0) and after 2 weeks (10 sessions)
Robertson Dysarthria profile
Time frame: Befofe the first tDCS session and after 2 weeks (10 sessions)
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 26 Nov 2025.
- Derived from this study: PubMed 41533249Sanna A, Pau M, Porta M, Pilia G, Secci V, Cartella E, Demattia A, Paribello A, Cossu G, Milia A, Tacconi P. Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-Controlled Clinical and Quantitative Analysis. Cerebellum. 2026 Jan 14;25(1):11. doi: 10.1007/s12311-025-01952-6.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) that will be collected throughout the trial will include all de-identified data relevant to the study's primary and secondary outcomes as well as demographic and clinical characteristics
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Ataxia, Cerebellar and Ataxia - Genetic Diagnosis - Unknown, run by University of Cagliari 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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?
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?
Modified International Cooperative Ataxia Rating Scale (MICARS) (time frame: Before the first tDCS session (T0) and after 10 sessions (2 weeks)). 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 NCT07250321, which also lists 1 linked publication.
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 26 Nov 2025.