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Effect of ctDCS During Balance Training on Cerebellar Ataxia

Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04039048
Enrollment
10
Registered
2019-07-31
Start date
2019-09-30
Completion date
2020-03-31
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance, Cerebellar Ataxia, Cerebellum; Injury

Keywords

Biodex balance system, Posture control, Ataxia' severity, ctDCS

Brief 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. 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.

Interventions

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.

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.

OTHERBalance training

Balance training will be performed through the Biodex Balance System for 20 minutes.

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cerebellar ataxia * Score \> 1 ≤ 4 on posture of Scale for assessment and rating of ataxia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in balance5 minutes before the intervention and 10 minutes after the interventionThe 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.

Secondary

MeasureTime frameDescription
Change in Ataxia' severity10 minutes before the intervention and 15 minutes after the interventionThe 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.
Change in functional mobility15 minutes before the intervention and 20 minutes after the interventionThe 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.

Countries

Brazil

Contacts

Primary ContactKátia Monte-Silva, PhD
monte.silvakk@gmail.com+55 81 2126-7579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026