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Trial record 6 of 219 for:    Ataxia

tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

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ClinicalTrials.gov Identifier: NCT03703830
Recruitment Status : Not yet recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco

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. Locomotor training (LT) 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 LT 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 LT; (ii) ctDCS sham associated with LT. The LT will be performed into two phases: (i) treadmill LT (for 25 minutes at a comfortable speed); and (ii) on the ground (20 minutes). The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during treadmill LT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance, postural stability 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), postural stability index by the Biodex balance system and TUG, respectively.

Condition or disease Intervention/treatment Phase
Ataxia, Cerebellar Device: Cerebellar transcranial direct current stimulation Other: Locomotor training Device: Sham Cerebellar transcranial direct current stimulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 28, 2020


Arm Intervention/treatment
Experimental: Experimental
Cerebellar transcranial current stimulation associated with locomotor training
Device: Cerebellar transcranial direct current stimulation
Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 3 cm below inion and cathodal electrode at right deltoid muscle.

Other: Locomotor training
The Locomotor Training (LT) will be performed into two phases: (i) treadmill LT (for 25 minutes at a comfortable speed and during ctDCS); and (ii) on the ground (20 minutes).
Other Names:
  • Treadmill locomotor training
  • Overground locomotor training

Sham Comparator: Sham comparator
Cerebellar transcranial current stimulation sham associated with locomotor training
Other: Locomotor training
The Locomotor Training (LT) will be performed into two phases: (i) treadmill LT (for 25 minutes at a comfortable speed and during ctDCS); and (ii) on the ground (20 minutes).
Other Names:
  • Treadmill locomotor training
  • Overground locomotor training

Device: Sham Cerebellar transcranial direct current stimulation
Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 3 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 Measures :
  1. Change in Functional mobility [ Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day ]
    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 :
  1. Change in Motor function [ Time Frame: Change from baseline(T0) at 7 (T7) and 14 days (T14) after the first intervention's day ]
    The motor function will be measured by a Baropodometric platform (Kinetec) for gait analyze. The subject will be asked to start to walk 2 meters before the platform and stop 2 meter after.

  2. Change in Fall risk [ Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. ]
    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.

  3. Change in Ataxia severity [ Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. ]
    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.

  4. Change in Postural stability [ Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. ]
    The postural stability will be assessed through the Postural Stability test of the Biodex Balance System SD (BBS). On this test, the patient has to maintain an unstable platform more stable possible, thereby less variation in sagittal and coronal plane, better postural stability.

  5. Change in Balance [ Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. ]
    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.

  6. Change in Patient global impression [ Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day ]
    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".

  7. Adverse effects of ctDCS [ Time Frame: 25 minutes after the beginning of stimulation ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03703830


Contacts
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Contact: Kátia Karina do Monte-Silva, PhD +55 81 9988631322 monte.silvakk@gmail.com

Sponsors and Collaborators
Universidade Federal de Pernambuco

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Responsible Party: Kátia Monte-Silva, Clinical Professor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03703830     History of Changes
Other Study ID Numbers: Cerebellarataxia_ctDCS_LT
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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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:
Cerebellum
Transcranial direct current stimulation
Gait ataxia

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