Cerebellar AtaxiaNCT04039048
Effect of ctDCS During Balance Training on Cerebellar Ataxia
A study testing cerebellar transcranial direct current stimulation and Balance training in people with Cerebellar Ataxia and Cerebellum; Injury, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebellar Ataxia, Cerebellum; Injury, Balance
- What is being tested?
- cerebellar transcranial direct current stimulation and Balance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebellar ataxia
- Score > 1 ≤ 4 on posture of Scale for 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 (3 months) during the period of study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Kátia Monte-Silva
Recife, Pernambuco, 50670-901
Kátia Monte-Silva, PhD, +55 81 2126-7579, monte.silvakk@gmail.com
About this study
Official title: Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.
- Conditions
- Cerebellar Ataxia, Cerebellum; Injury, Balance
- Being tested
- cerebellar transcranial direct current stimulation, Sham cerebellar transcranial direct current stimulation, Balance training
- Keywords
- Biodex balance system, Posture control, Ataxia' severity, ctDCS
- Medical subject headings
- Cerebellar Ataxia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebellar transcranial direct current stimulationDevice
Also called ctDCS
Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 20 minutes with a 2mA current.
Sham cerebellar transcranial direct current stimulationDevice
Also called ctDCS sham
Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 30 seconds with a 2mA current.
Balance trainingOther
Balance training will be performed through the Biodex Balance System for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ctDCS during Balance training | Experimental | Not described Receives: Device: cerebellar transcranial direct current stimulation; Other: Balance training |
| ctDCS sham during Balance training | Sham comparator | Not described Receives: Device: Sham cerebellar transcranial direct current stimulation; Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in balance
The change in balance will be assessed through postural control index of Biodex Balance System. This postural control index is a continuous variable where lower index means less instability and better balance.
Measured: 5 minutes before the intervention and 10 minutes after the intervention
Secondary outcomes (2)
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 higher score (40) mean more severe ataxia, whereas lower score (0) means less ataxia symptoms. The score happens about the sum of the eight items.
Measured: 10 minutes before the intervention and 15 minutes after the intervention
Change in functional mobility
The patient will walk 10 meters and the time will be measured to determine the functional mobility. Where lower time to walk 10 meters, better functional mobility.
Measured: 15 minutes before the intervention and 20 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study startSep 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (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 Cerebellar AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 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
- NCT04039048
- Sponsor's protocol ID
- cerebellarataxia_balance_ctDCS
- Status last verified
- Aug 2019
- First submitted
- 28 Jul 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brito R, Fabricio JV, Araujo A, Barreto G, Baltar A, Monte-Silva K. Single-Session Cerebellar Transcranial Direct Current Stimulation Improves Postural Stability and Reduces Ataxia Symptoms in Spinocerebellar Ataxia. Cerebellum. 2024 Oct;23(5):1993-2002. doi: 10.1007/s12311-024-01696-9. Epub 2024 May 2.
PubMed 38693314
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT04039048
- Acronym / sponsor ID
- cerebellarataxia_balance_ctDCS
- Conditions
- Cerebellar Ataxia, Cerebellum; Injury, Balance
- Keywords
- Biodex balance system, Posture control, Ataxia' severity, ctDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 31 Jul 2019 (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 damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDCS during Balance training | Experimental | Device: cerebellar transcranial direct current stimulation, Other: Balance training |
| ctDCS sham during Balance training | Sham comparator | Device: Sham cerebellar transcranial direct current stimulation, Other: Balance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cerebellar ataxia
- Score > 1 ≤ 4 on posture of Scale for 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 (3 months) 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 stimulationAlso: ctDCSNon-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 20 minutes with a 2mA current. | Device | ctDCS during Balance training |
| Sham cerebellar transcranial direct current stimulationAlso: ctDCS shamNon-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 30 seconds with a 2mA current. | Device | ctDCS sham during Balance training |
| Balance trainingBalance training will be performed through the Biodex Balance System for 20 minutes. | Other | ctDCS during Balance training, ctDCS sham during Balance training |
Primary outcome
Change in balance
Time frame: 5 minutes before the intervention and 10 minutes after the intervention
The change in balance will be assessed through postural control index of Biodex Balance System. This postural control index is a continuous variable where lower index means less instability and better balance.
2 secondary outcomes
Change in Ataxia' severity
Time frame: 10 minutes before the intervention and 15 minutes after the intervention
Change in functional mobility
Time frame: 15 minutes before the intervention and 20 minutes after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 38693314Brito R, Fabricio JV, Araujo A, Barreto G, Baltar A, Monte-Silva K. Single-Session Cerebellar Transcranial Direct Current Stimulation Improves Postural Stability and Reduces Ataxia Symptoms in Spinocerebellar Ataxia. Cerebellum. 2024 Oct;23(5):1993-2002. doi: 10.1007/s12311-024-01696-9. Epub 2024 May 2.
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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.
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 and Balance training in people with Cerebellar Ataxia and Cerebellum; Injury, 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 2 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 16 Aug 2019. 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?
Contact Kátia Monte-Silva, PhD (+55 81 2126-7579, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in balance (time frame: 5 minutes before the intervention and 10 minutes after the intervention). 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 NCT04039048, 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 16 Aug 2019.