Clinical trial NCT03703830: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ataxia, Cerebellar
Keywords: Cerebellum
Transcranial direct current stimulation
Gait ataxia
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Functional mobility
timeFrame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Secondary outcomes:
measure: Change in Fall risk
timeFrame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
measure: Change in Ataxia severity
timeFrame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
measure: Change in Balance
timeFrame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
measure: Change in Patient global impression
timeFrame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
measure: Adverse effects of ctDCS
timeFrame: 25 minutes after the beginning of stimulation
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Kátia Monte-Silva
state: Pernambuco
Study officials:
References: