Ataxias EspinocerebelaresNCT06974149
Effects of Transcranial Direct Current Stimulation Associated With Neurofunctional Rehabilitation in Individuals With Spinocerebellar Ataxias
A study testing Neurofunctional Rehabilitation and transcranial direct current stimulation in people with Ataxias Espinocerebelares, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the effects of . Transcranial direct current stimulation (tDCS) combined with neurofunctional rehabilitation on disease severity in individuals with neurodegenerative ataxias. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ataxias Espinocerebelares
- What is being tested?
- Neurofunctional Rehabilitation and transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jul 2025to Feb 2029
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of spinocerebellar ataxias;
- Walking independently or with aids;
Who cannot join
- Metal implants in the brain or spinal column and Cochlear implants;
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Transcranial Direct Current Stimulation Associated With Neurofunctional Rehabilitation in Individuals With Spinocerebellar Ataxias - Randomized Clinical Trial
The aim of this study is to evaluate the effects of . Transcranial direct current stimulation (tDCS) combined with neurofunctional rehabilitation on disease severity in individuals with neurodegenerative ataxias. The study will compare whether the Neurofunctional Rehabilitation Protocol combined with real tDCS will bring better results in reducing disease severity compared to the neurofunctional rehabilitation protocol combined with simulated tDCS.
Read the detailed description
Neurodegenerative ataxias are a group of heterogeneous and progressive diseases that affect the cerebellum. Symptoms related to these diseases include difficulties with walking, balance, and motor coordination. Neurofunctional rehabilitation can help improve these motor symptoms. However, it is still limited in reducing neurodegeneration. Transcranial direct current stimulation (tDCS) applied to the cerebellum has shown to be a promising treatment in reducing disease severity, improving balance, and improving the quality of life of these individuals. tDCS in combination with neurofunctional rehabilitation may be a beneficial alternative in neurodegenerative ataxias, but studies are lacking. Regarding neurofunctional rehabilitation, some studies have shown improvements in reducing the progression of this pathology. However, as a rule, these studies presented poorly detailed protocols. Furthermore, the study populations included several types of cerebellar ataxias. Therefore, a detailed description of physiotherapy exercises, also recording them in images, with a more homogeneous sample, can ensure the viability of a more efficient treatment. tDCS applied to ataxia, in turn, presented beneficial results regarding disease progression, walking speed, balance and, also, quality of life. tDCS can enhance the effects of neurofunctional rehabilitation, as has already been proven in other populations. The combination of tDCS with neurofunctional rehabilitation is still poorly described in the literature in patients with neurodegenerative ataxias. Therefore, it is necessary to conduct a study specifically designed to test the hypothesis that tDCS combined with neurofunctional rehabilitation will demonstrate better results in relation to disease severity, postural control, risk of falls, quality of life and fatigue. In this case, a ten-session protocol can be applied, evaluating the results in 5 (five) ,10 (ten) and 20 (twenty)sessions, positioning the anode in the cerebellum and the cathode in the spinal cord, with patient monitoring for 16 (sixteen) weeks. This study can, finally, compare the results between neurofunctional rehabilitation combined with tDCS and neurofunctional rehabilitation alone
- Conditions
- Ataxias Espinocerebelares
- Being tested
- Neurofunctional Rehabilitation, transcranial direct current stimulation
- Keywords
- Ataxias espinocerebelares, estimulação transcraniana por corrente contínua, reabilitação neurológica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofunctional RehabilitationOther
Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs
transcranial direct current stimulationDevice
Transcranial direct current stimulation will be applied for 20 minutes at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11)
Neurofunctional RehabilitationOther
Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs
transcranial direct current stimulationDevice
Transcranial direct current stimulation will be applied for 30 seconds at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11). However the electrodes will be kept for 20 minutes to mask the stimulation
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation associated with neurofunctional rehabilitation | Active comparator | Not described Receives: Other: Neurofunctional Rehabilitation; Device: transcranial direct current stimulation |
| transcranial direct current stimulation simulated associated with neurofunctional rehabilitation | Sham comparator | Not described Receives: Other: Neurofunctional Rehabilitation; Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment and Rating of Ataxia (SARA)
The severity of ataxia will be assessed using the Ataxia Rating and Assessment (SARA) scale, which consists of eight items: gait, posture, sitting, speech, finger-chasing, nose-finger test, rapid alternation of hand movements, and lower limb coordination. The higher the score, the greater the severity of the disease.
Measured: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Secondary outcomes (8)
Mini-BEST test
The Mini-BEST is an instrument that assesses postural control. The Mini-BEST includes 14 items divided into: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The following tasks will be assessed: sitting to standing, standing on tiptoe, single-leg support, correction with anterior, posterior, and lateral steps, eyes open on a firm surface, eyes closed on an unstable surface, tilt with eyes closed, change in gait speed, walking with head turns, walking and turning on the axis, passing through obstacles, gait speed with and without dual task. The individual may use an assistive device during the test, if necessary, but each domain will be scored one level below the item for which the device was used . The maximum score is 28 (twenty-eight) points; Items can be scored as 0 (unable),
Measured: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Stabilometry
Stabilometry assesses balance in the orthostatic posture and quantifies the anteroposterior and lateral oscillations of the body's center of pressure (COP). This analysis will be performed using a Baiobit inertial sensor (BTS Bioengineering). The sensor will be connected to the individual by an elastic belt placed at the height of the S1-S2 vertebrae. The patient will remain in a bipedal position for 30 (thirty) seconds. The sensor will measure the following indices: angle of oscillations, elliptical area, oscillations, speed of anteroposterior and lateral oscillations of the center of mass and the length of the trajectory of the center of mass.
Measured: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Falls Efficacy Scale-International (FES-I)
This scale assesses the risk of falls. It is a questionnaire of self-efficacy and confidence in balance, with 16 (sixteen) items. It includes questions about activities of daily living in the home environment and in the community environment. Response options include: not at all concerned, somewhat concerned, very concerned and extremely concerned.
The score ranges from a minimum of 16 (no concern about falls) to a maximum of 64 (severe concern about falls). Therefore, the higher the score, the greater the risk of falls.
Measured: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
Timed Up and Go (TUG)
The Timed Up Go (TUG) test will be used to assess functional mobility and the risk of falls. The test identifies the speed at which the patient can get up from a chair, walk 3 (three) meters, return and sit down. The time spent performing the task can be classified as low risk, medium risk and high risk of falls. During the test, the patient will be wearing a Baiobit inertial sensor (BTS Bioengineering). The sensor will be connected to the individual by an elastic belt placed at the height of the S1-S2 vertebrae. This sensor will assess the duration of the TUG phases (sitting to standing, walking, turning and standing to sitting).
Measured: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
8-meter walk test (8mWT)
The 8-meter walk test is a functional assessment that measures an individual's walking speed. The test will be performed indoors on a flat surface, on a path marked out at 8 meters. Adhesive tape will be used to clearly mark the start and end of the path, and a stopwatch will be used to measure walking time. Individuals will be instructed to walk "as quickly but safely as possible." If necessary, individuals may use any assistive device, but without the help of another person or a wall. Three (3) repetitions will be performed, with a 1 (one) minute recovery interval between each repetition. The average time will be calculated and from this average the speed will be determined using the equation: Speed = distance traveled/time.
Measured: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
Gait analysis
This analysis will be performed using a Baiobit inertial sensor (BTS Bioengineering). The sensor will be connected to the individual by an elastic belt placed at the height of the S1-S2 vertebrae. The individuals will be instructed to walk a distance of 7 meters. The following variables will be collected: speed (m/s), cadence (steps/min), stride length (meters), number of steps, stance phase (% of cycle) and swing phase (% of cycle).
Measured: baseline, at the end of 5,10 and 20 sessions e follow up ( 2 and 4 months)
Form Health Survey 36 (SF-36)
Quality of life will be assessed using the Form Health Survey 36 (SF-36), a questionnaire consisting of 36 scores that assess 8 subdomains: vitality, limitation due to physical aspect, functional capacity, bodily pain, general health perceptions, social aspects, emotional aspects and mental health . This instrument has been translated and culturally validated for the Brazilian population . It presents a score from 0 to 100, in which zero corresponds to the "worst general health status" and 100 the "best general health status" .
Measured: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
Modified Fatigue Impact Scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) is a scale that assesses fatigue. It consists of 21 statements that assess the physical, cognitive and psychosocial domains. The individual must choose an alternative (scored from 0 to 4) for each item. Possible answers include: "never", "rarely", "rarely", "often" and "always". To answer it, the last two weeks up to the present day must be considered. The total MFIS score ranges from 0 to 84 and is calculated by adding the statements. Its objective is to assess the impact of fatigue on the patient's life. Values below 38 correspond to the absence of fatigue. For scores equal to or greater than 38, the higher the score, the greater the impact of fatigue
Measured: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start7 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxias EspinocerebelaresStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974149
- Sponsor's protocol ID
- FUHSPortoAlegreMarianaBrutto
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Direct Current Stimulation Associated With Neurofunctional Rehabilitation in Individuals With Spinocerebellar Ataxias - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06974149
- Acronym / sponsor ID
- FUHSPortoAlegreMarianaBrutto
- Conditions
- Ataxias Espinocerebelares
- Keywords
- Ataxias espinocerebelares, estimulação transcraniana por corrente contínua, reabilitação neurológica
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 15 May 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.
The aim of this study is to evaluate the effects of . Transcranial direct current stimulation (tDCS) combined with neurofunctional rehabilitation on disease severity in individuals with neurodegenerative ataxias. The study will compare whether the Neurofunctional Rehabilitation Protocol combined with real tDCS will bring better results in reducing disease severity compared to the neurofunctional rehabilitation protocol combined with simulated tDCS.
Detailed description
Neurodegenerative ataxias are a group of heterogeneous and progressive diseases that affect the cerebellum. Symptoms related to these diseases include difficulties with walking, balance, and motor coordination. Neurofunctional rehabilitation can help improve these motor symptoms. However, it is still limited in reducing neurodegeneration. Transcranial direct current stimulation (tDCS) applied to the cerebellum has shown to be a promising treatment in reducing disease severity, improving balance, and improving the quality of life of these individuals. tDCS in combination with neurofunctional rehabilitation may be a beneficial alternative in neurodegenerative ataxias, but studies are lacking. Regarding neurofunctional rehabilitation, some studies have shown improvements in reducing the progression of this pathology. However, as a rule, these studies presented poorly detailed protocols. Furthermore, the study populations included several types of cerebellar ataxias. Therefore, a detailed description of physiotherapy exercises, also recording them in images, with a more homogeneous sample, can ensure the viability of a more efficient treatment. tDCS applied to ataxia, in turn, presented beneficial results regarding disease progression, walking speed, balance and, also, quality of life. tDCS can enhance the effects of neurofunctional rehabilitation, as has already been proven in other populations. The combination of tDCS with neurofunctional rehabilitation is still poorly described in the literature in patients with neurodegenerative ataxias. Therefore, it is necessary to conduct a study specifically designed to test the hypothesis that tDCS combined with neurofunctional rehabilitation will demonstrate better results in relation to disease severity, postural control, risk of falls, quality of life and fatigue. In this case, a ten-session protocol can be applied, evaluating the results in 5 (five) ,10 (ten) and 20 (twenty)sessions, positioning the anode in the cerebellum and the cathode in the spinal cord, with patient monitoring for 16 (sixteen) weeks. This study can, finally, compare the results between neurofunctional rehabilitation combined with tDCS and neurofunctional rehabilitation alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation associated with neurofunctional rehabilitation | Active comparator | Other: Neurofunctional Rehabilitation, Device: transcranial direct current stimulation |
| transcranial direct current stimulation simulated associated with neurofunctional rehabilitation | Sham comparator | Other: Neurofunctional Rehabilitation, Device: transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of spinocerebellar ataxias;
- Walking independently or with aids;
Key exclusion criteria (2 listed)
- Metal implants in the brain or spinal column and Cochlear implants;
- Pregnant women
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 |
|---|---|---|
| Neurofunctional RehabilitationNeurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs | Other | transcranial direct current stimulation associated with neurofunctional rehabilitation |
| transcranial direct current stimulationTranscranial direct current stimulation will be applied for 20 minutes at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11) | Device | transcranial direct current stimulation associated with neurofunctional rehabilitation |
| Neurofunctional RehabilitationNeurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs | Other | transcranial direct current stimulation simulated associated with neurofunctional rehabilitation |
| transcranial direct current stimulationTranscranial direct current stimulation will be applied for 30 seconds at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11). However the electrodes will be kept for 20 minutes to mask the stimulation | Device | transcranial direct current stimulation simulated associated with neurofunctional rehabilitation |
Primary outcome
Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
The severity of ataxia will be assessed using the Ataxia Rating and Assessment (SARA) scale, which consists of eight items: gait, posture, sitting, speech, finger-chasing, nose-finger test, rapid alternation of hand movements, and lower limb coordination. The higher the score, the greater the severity of the disease.
8 secondary outcomes
Mini-BEST test
Time frame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Stabilometry
Time frame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Falls Efficacy Scale-International (FES-I)
Time frame: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
Timed Up and Go (TUG)
Time frame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
8-meter walk test (8mWT)
Time frame: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
Gait analysis
Time frame: baseline, at the end of 5,10 and 20 sessions e follow up ( 2 and 4 months)
Form Health Survey 36 (SF-36)
Time frame: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
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 16 Mar 2026.
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 Neurofunctional Rehabilitation and transcranial direct current stimulation in people with Ataxias Espinocerebelares, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 2 inclusion and 2 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 16 Mar 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 Brazil. 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?
Scale for the Assessment and Rating of Ataxia (SARA) (time frame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.