tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia

Sponsors

Lead Sponsor: Universidade Federal de Pernambuco

Source 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. 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.

Overall Status Recruiting
Start Date November 1, 2018
Completion Date February 28, 2020
Primary Completion Date January 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Functional mobility Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Secondary Outcome
Measure Time Frame
Change in Fall risk Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Ataxia severity Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Balance Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Change in Patient global impression Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Adverse effects of ctDCS 25 minutes after the beginning of stimulation
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: Cerebellar transcranial direct current stimulation

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.

Arm Group Label: Experimental

Intervention Type: Other

Intervention Name: Treadmill locomotor training

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: Sham Cerebellar transcranial direct current stimulation

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.

Arm Group Label: Sham comparator

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Contact

Last Name: Kátia Monte-Silva, PhD

Phone: +55 81 9988631322

Email: [email protected]

Location
Facility: Status: Contact: Kátia Monte-Silva Kátia Monte-Silva, PhD +55 81 2126-7579 [email protected]
Location Countries

Brazil

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universidade Federal de Pernambuco

Investigator Full Name: Kátia Monte-Silva

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental

Type: Experimental

Description: Cerebellar transcranial current stimulation associated with locomotor training

Label: Sham comparator

Type: Sham Comparator

Description: Cerebellar transcranial current stimulation sham associated with locomotor training

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov

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