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Effect of ctDCS During Balance Training on Cerebellar Ataxia

U

Universidade Federal de Pernambuco

Status

Unknown

Conditions

Balance
Cerebellum; Injury
Cerebellar Ataxia

Treatments

Device: Sham cerebellar transcranial direct current stimulation
Other: Balance training
Device: cerebellar transcranial direct current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04039048
cerebellarataxia_balance_ctDCS

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups

ctDCS during Balance training
Experimental group
Treatment:
Device: cerebellar transcranial direct current stimulation
Other: Balance training
ctDCS sham during Balance training
Sham Comparator group
Treatment:
Other: Balance training
Device: Sham cerebellar transcranial direct current stimulation

Trial contacts and locations

1

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Central trial contact

Kátia Monte-Silva, PhD

Data sourced from clinicaltrials.gov

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