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Effect of ctDCS During Balance Training on Cerebellar Ataxia

Primary Purpose

Cerebellar Ataxia, Cerebellum; Injury, Balance

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
cerebellar transcranial direct current stimulation
Sham cerebellar transcranial direct current stimulation
Balance training
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia focused on measuring Biodex balance system, Posture control, Ataxia' severity, ctDCS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kátia Monte-SilvaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ctDCS during Balance training

ctDCS sham during Balance training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 28, 2019
Last Updated
August 13, 2019
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT04039048
Brief Title
Effect of ctDCS During Balance Training on Cerebellar Ataxia
Official Title
Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia, Cerebellum; Injury, Balance
Keywords
Biodex balance system, Posture control, Ataxia' severity, ctDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ctDCS during Balance training
Arm Type
Experimental
Arm Title
ctDCS sham during Balance training
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
cerebellar transcranial direct current stimulation
Other Intervention Name(s)
ctDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham cerebellar transcranial direct current stimulation
Other Intervention Name(s)
ctDCS sham
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Balance training
Intervention Description
Balance training will be performed through the Biodex Balance System for 20 minutes.
Primary Outcome Measure Information:
Title
Change in balance
Description
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.
Time Frame
5 minutes before the intervention and 10 minutes after the intervention
Secondary Outcome Measure Information:
Title
Change in Ataxia' severity
Description
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.
Time Frame
10 minutes before the intervention and 15 minutes after the intervention
Title
Change in functional mobility
Description
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.
Time Frame
15 minutes before the intervention and 20 minutes after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kátia Monte-Silva, PhD
Phone
+55 81 2126-7579
Email
monte.silvakk@gmail.com
Facility Information:
Facility Name
Kátia Monte-Silva
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kátia Monte-Silva, PhD
Phone
+55 81 2126-7579
Email
monte.silvakk@gmail.com

12. IPD Sharing Statement

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Effect of ctDCS During Balance Training on Cerebellar Ataxia

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