tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia
Primary Purpose
Ataxia, Cerebellar
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cerebellar transcranial direct current stimulation
Treadmill locomotor training
Sham Cerebellar transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Ataxia, Cerebellar focused on measuring Cerebellum, Transcranial direct current stimulation, Gait ataxia
Eligibility Criteria
Inclusion Criteria:
- Cerebellar ataxia
- Ages: 18 to 65 years;
- Gender: Both;
- Score ≥ 3 and < 8 in subscore of gait in the Scale for the 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 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
Experimental
Sham comparator
Arm Description
Cerebellar transcranial current stimulation associated with locomotor training
Cerebellar transcranial current stimulation sham associated with locomotor training
Outcomes
Primary Outcome Measures
Change in Functional mobility
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.
Secondary Outcome Measures
Change in Fall risk
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer time values and step numbers represent a greater risk of falls. Time greater than 10 seconds in the test means greater risk of falling.
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 ranges from 0 to 40. Higher score mean more severe ataxia.
Change in Balance
The balance of individuals will be assessed through the Balance Evaluation System Test (BESt), which comprises 14 items with a score of 0-2 each from 0 (worst) to 2 (best performance), used to assess dysfunction in balance and independence in life activities daily.
Change in Patient global impression
The patient's global impression is a questionnaire which the patient has to answer how the treatment changed his life daily activities. Patient will choose the best option that reflects their improvement in quality of life, from "no change" to "much better with differences that have made all the difference".
Adverse effects of ctDCS
Brunoni's questionnaire will be used to ask the patient about some possible adverse effects related to stimulations. The patient will be asked always at the end of each stimulation (real or sham).
Full Information
NCT ID
NCT03703830
First Posted
October 5, 2018
Last Updated
July 28, 2019
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03703830
Brief Title
tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia
Official Title
Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
February 28, 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
5. Study Description
Brief Summary
Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia, Cerebellar
Keywords
Cerebellum, Transcranial direct current stimulation, Gait ataxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Cerebellar transcranial current stimulation associated with locomotor training
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm Description
Cerebellar transcranial current stimulation sham associated with locomotor training
Intervention Type
Device
Intervention Name(s)
Cerebellar transcranial direct current stimulation
Intervention Description
Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle.
Intervention Type
Other
Intervention Name(s)
Treadmill locomotor training
Intervention Description
The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS
Intervention Type
Device
Intervention Name(s)
Sham Cerebellar transcranial direct current stimulation
Intervention Description
Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.
Primary Outcome Measure Information:
Title
Change in Functional mobility
Description
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.
Time Frame
Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Secondary Outcome Measure Information:
Title
Change in Fall risk
Description
The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer time values and step numbers represent a greater risk of falls. Time greater than 10 seconds in the test means greater risk of falling.
Time Frame
Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
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 ranges from 0 to 40. Higher score mean more severe ataxia.
Time Frame
Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Title
Change in Balance
Description
The balance of individuals will be assessed through the Balance Evaluation System Test (BESt), which comprises 14 items with a score of 0-2 each from 0 (worst) to 2 (best performance), used to assess dysfunction in balance and independence in life activities daily.
Time Frame
Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Title
Change in Patient global impression
Description
The patient's global impression is a questionnaire which the patient has to answer how the treatment changed his life daily activities. Patient will choose the best option that reflects their improvement in quality of life, from "no change" to "much better with differences that have made all the difference".
Time Frame
Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Title
Adverse effects of ctDCS
Description
Brunoni's questionnaire will be used to ask the patient about some possible adverse effects related to stimulations. The patient will be asked always at the end of each stimulation (real or sham).
Time Frame
25 minutes after the beginning of stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cerebellar ataxia
Ages: 18 to 65 years;
Gender: Both;
Score ≥ 3 and < 8 in subscore of gait in the Scale for the 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 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 9988631322
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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tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia
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