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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04039048
Other study ID # cerebellarataxia_balance_ctDCS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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