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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

Tracking Information
First Submitted Date  ICMJE July 28, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date August 16, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2019)
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 of biodex balance system
Change History Complete list of historical versions of study NCT04039048 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2019)
  • 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 mean more severe ataxia
  • 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 mensured to determine the functional mobility
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of ctDCS During Balance Training on Cerebellar Ataxia
Official Title  ICMJE Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebellar Ataxia
  • Cerebellum; Injury
  • Balance
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: ctDCS during Balance training
    Interventions:
    • Device: cerebellar transcranial direct current stimulation
    • Other: Balance training
  • Sham Comparator: ctDCS sham during Balance training
    Interventions:
    • Device: Sham cerebellar transcranial direct current stimulation
    • Other: Balance training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kátia Monte-Silva, PhD +55 81 2126-7579 monte.silvakk@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039048
Other Study ID Numbers  ICMJE cerebellarataxia_balance_ctDCS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kátia Monte-Silva, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Universidade Federal de Pernambuco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Pernambuco
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP