tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

Ataxia, Cerebellar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03703830
• Other study ID #: Cerebellarataxia_ctDCS_LT
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Ataxia, Cerebellar
• Cerebellar Ataxia

Intervention

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 1 cm below inion and cathodal electrode at right deltoid muscle.

Other:
• Treadmill locomotor training
The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS

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 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.
• Cerebello-spinal direct current stimulation
Cerebello-spinal transcranial direct current stimulation (csDCS) will be applied during 25 minutes at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11)
• Sham cerebello-spinal direct current stimulation
Sham cerebello-spinal direct current stimulation (csDCS sham) will be applied during 30 seconds at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11). However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.

Locations

Country	Name	City	State
Brazil	Kátia Monte-Silva	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Secondary	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 from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Secondary	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 from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Secondary	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 from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.
Secondary	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".	Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day
Secondary	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).	25 minutes after the beginning of stimulation