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Effect of ctDCS During Balance Training on Cerebellar Ataxia

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ClinicalTrials.gov Identifier: NCT04039048
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Cerebellar Ataxia Cerebellum; Injury Balance Device: cerebellar transcranial direct current stimulation Device: Sham cerebellar transcranial direct current stimulation Other: Balance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: ctDCS during Balance training Device: cerebellar transcranial direct current stimulation
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.
Other Name: ctDCS

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

Sham Comparator: ctDCS sham during Balance training Device: Sham cerebellar transcranial direct current stimulation
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.
Other Name: ctDCS sham

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Ataxia' severity [ Time Frame: 10 minutes before the intervention and 15 minutes after the intervention ]
    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.

  2. Change in functional mobility [ Time Frame: 15 minutes before the intervention and 20 minutes after the intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039048


Contacts
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Contact: Kátia Monte-Silva, PhD +55 81 2126-7579 monte.silvakk@gmail.com

Locations
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Brazil
Kátia Monte-Silva Recruiting
Recife, Pernambuco, Brazil, 50670-901
Contact: Kátia Monte-Silva, PhD    +55 81 2126-7579    monte.silvakk@gmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco

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Responsible Party: Kátia Monte-Silva, Study director, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT04039048     History of Changes
Other Study ID Numbers: cerebellarataxia_balance_ctDCS
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:
Biodex balance system
Posture control
Ataxia' severity
ctDCS
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases