Ataxia, CerebellarNCT03703830
tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia
A study testing Cerebellar transcranial direct current stimulation, Treadmill locomotor training and Cerebello-spinal direct current stimulation in people with Ataxia, Cerebellar, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ataxia, Cerebellar
- What is being tested?
- Cerebellar transcranial direct current stimulation, Treadmill locomotor training and Cerebello-spinal direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2018to 31 Jul 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebellar ataxia
- Ages: 18 to 65 years;
- Gender: Both;
- Score ≥ 3 and < 8 in subscore of gait in the Scale for the Assessment and Rating of Ataxia
Who cannot join
- Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
- Pacemaker;
- History of seizures;
- Metallic implants in the head or neck;
- Medication change during the period of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia
Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.
- Conditions
- Ataxia, Cerebellar
- Being tested
- Cerebellar transcranial direct current stimulation, Treadmill locomotor training, Sham Cerebellar transcranial direct current stimulation, Cerebello-spinal direct current stimulation, Sham cerebello-spinal direct current stimulation
- Keywords
- Cerebellum, Transcranial direct current stimulation, Gait ataxia
- Medical subject headings
- Cerebellar Ataxia, Gait Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar transcranial direct current stimulationDevice
Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle.
Treadmill locomotor trainingOther
The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS
Sham Cerebellar transcranial direct current stimulationDevice
Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.
Cerebello-spinal direct current stimulationDevice
Cerebello-spinal transcranial direct current stimulation (csDCS) will be applied during 25 minutes at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11)
Sham cerebello-spinal direct current stimulationDevice
Sham cerebello-spinal direct current stimulation (csDCS sham) will be applied during 30 seconds at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11). However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.
| Study group | Role | What they receive |
|---|---|---|
| Experimental I | Experimental | Cerebellar transcranial current stimulation associated with locomotor training Receives: Device: Cerebellar transcranial direct current stimulation; Other: Treadmill locomotor training |
| Sham comparator I | Sham comparator | Cerebellar transcranial current stimulation sham associated with locomotor training Receives: Other: Treadmill locomotor training; Device: Sham Cerebellar transcranial direct current stimulation |
| Experimental II | Experimental | Cerebello-spinal direct current stimulation associated with locomotor training Receives: Other: Treadmill locomotor training; Device: Cerebello-spinal direct current stimulation |
| Sham comparator II | Sham comparator | Cerebello-spinal direct current stimulation sham associated with locomotor training Receives: Other: Treadmill locomotor training; Device: Sham cerebello-spinal direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional mobility
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.
Measured: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Secondary outcomes (5)
Change in Fall risk
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer time values and step numbers represent a greater risk of falls. Time greater than 10 seconds in the test means greater risk of falling.
Measured: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Ataxia severity
The ataxia' severity will be assessed by the Scale for the Assessment and Rating of Ataxia (SARA). It consists of eight items (gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating, hand movements, and heel-shin slide), where ranges from 0 to 40. Higher score mean more severe ataxia.
Measured: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Balance
The balance of individuals will be assessed through the Balance Evaluation System Test (BESt), which comprises 14 items with a score of 0-2 each from 0 (worst) to 2 (best performance), used to assess dysfunction in balance and independence in life activities daily.
Measured: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Patient global impression
The patient's global impression is a questionnaire which the patient has to answer how the treatment changed his life daily activities. Patient will choose the best option that reflects their improvement in quality of life, from "no change" to "much better with differences that have made all the difference".
Measured: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Adverse effects of ctDCS
Brunoni's questionnaire will be used to ask the patient about some possible adverse effects related to stimulations. The patient will be asked always at the end of each stimulation (real or sham).
Measured: 25 minutes after the beginning of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Jul 2024 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703830
- Sponsor's protocol ID
- Cerebellarataxia_ctDCS_LT
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2018
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brito R, Lima FA, Ribeiro AC, Fabricio JV, Melo D, Guerra S, Sacchi M, Barreto G, Baltar A, Tanaka C, Monte-Silva K. Brief protocol to improve ataxia symptoms via cerebello-spinal direct current stimulation during gait training. Clin Neurophysiol. 2026 Jul;187:2111882. doi: 10.1016/j.clinph.2026.2111882. Epub 2026 Apr 3.
PubMed 41996751
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT03703830
- Acronym / sponsor ID
- Cerebellarataxia_ctDCS_LT
- Conditions
- Ataxia, Cerebellar
- Keywords
- Cerebellum, Transcranial direct current stimulation, Gait ataxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Oct 2018 (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.
Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental I | Experimental | Device: Cerebellar transcranial direct current stimulation, Other: Treadmill locomotor trainingCerebellar transcranial current stimulation associated with locomotor training |
| Sham comparator I | Sham comparator | Other: Treadmill locomotor training, Device: Sham Cerebellar transcranial direct current stimulationCerebellar transcranial current stimulation sham associated with locomotor training |
| Experimental II | Experimental | Other: Treadmill locomotor training, Device: Cerebello-spinal direct current stimulationCerebello-spinal direct current stimulation associated with locomotor training |
| Sham comparator II | Sham comparator | Other: Treadmill locomotor training, Device: Sham cerebello-spinal direct current stimulationCerebello-spinal direct current stimulation sham associated with locomotor training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cerebellar ataxia
- Ages: 18 to 65 years;
- Gender: Both;
- Score ≥ 3 and < 8 in subscore of gait in the Scale for the Assessment and Rating of Ataxia
Key exclusion criteria (5 listed)
- Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
- Pacemaker;
- History of seizures;
- Metallic implants in the head or neck;
- Medication change during the period of study
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 |
|---|---|---|
| Cerebellar transcranial direct current stimulationCerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. | Device | Experimental I |
| Treadmill locomotor trainingThe Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS | Other | Experimental I, Experimental II, Sham comparator I, Sham comparator II |
| Sham Cerebellar transcranial direct current stimulationSham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking. | Device | Sham comparator I |
| Cerebello-spinal direct current stimulationCerebello-spinal transcranial direct current stimulation (csDCS) will be applied during 25 minutes at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11) | Device | Experimental II |
| Sham cerebello-spinal direct current stimulationSham cerebello-spinal direct current stimulation (csDCS sham) will be applied during 30 seconds at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11). However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking. | Device | Sham comparator II |
Primary outcome
Change in Functional mobility
Time frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.
5 secondary outcomes
Change in Fall risk
Time frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Ataxia severity
Time frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Balance
Time frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Patient global impression
Time frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Adverse effects of ctDCS
Time frame: 25 minutes after the beginning of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 41996751Brito R, Lima FA, Ribeiro AC, Fabricio JV, Melo D, Guerra S, Sacchi M, Barreto G, Baltar A, Tanaka C, Monte-Silva K. Brief protocol to improve ataxia symptoms via cerebello-spinal direct current stimulation during gait training. Clin Neurophysiol. 2026 Jul;187:2111882. doi: 10.1016/j.clinph.2026.2111882. Epub 2026 Apr 3.
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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 Cerebellar transcranial direct current stimulation, Treadmill locomotor training and Cerebello-spinal direct current stimulation in people with Ataxia, Cerebellar, run by Universidade Federal de Pernambuco 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 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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?
Results are not available in the source record.
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 Functional mobility (time frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day). 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 NCT03703830, 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 Feb 2024.