Effect of ctDCS During Balance Training on Cerebellar Ataxia

Balance Clinical Trial

Official title:

Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039048
• Other study ID #: cerebellarataxia_balance_ctDCS
• Status: Recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: March 2020

Study information

• Verified date: August 2019
• Source: Universidade Federal de Pernambuco
• Contact: Kátia Monte-Silva, PhD
• Phone: +55 81 2126-7579
• Email: monte.silvakk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cerebellar ataxia

• Score > 1 = 4 on posture of Scale for 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 (3 months) during the period of study

Related Conditions & MeSH terms

• Ataxia
• Balance
• Cerebellar Ataxia
• Cerebellum; Injury

Intervention

Device:
• cerebellar transcranial direct current stimulation
Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 20 minutes with a 2mA current.
• Sham cerebellar transcranial direct current stimulation
Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 30 seconds with a 2mA current.

Other:
• Balance training
Balance training will be performed through the Biodex Balance System for 20 minutes.

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 balance	The change in balance will be assessed through postural control index of Biodex Balance System. This postural control index is a continuous variable where lower index means less instability and better balance.	5 minutes before the intervention and 10 minutes after the intervention
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 higher score (40) mean more severe ataxia, whereas lower score (0) means less ataxia symptoms. The score happens about the sum of the eight items.	10 minutes before the intervention and 15 minutes after the intervention
Secondary	Change in functional mobility	The patient will walk 10 meters and the time will be measured to determine the functional mobility. Where lower time to walk 10 meters, better functional mobility.	15 minutes before the intervention and 20 minutes after the intervention