Effect of ctDCS During Balance Training on Cerebellar Ataxia

• ClinicalTrials.gov Identifier: NCT04039048
• Recruitment Status: Recruiting
• First Posted: July 31, 2019
• Last Update Posted: August 16, 2019
• Sponsor: Universidade Federal de Pernambuco
• Information provided by (Responsible Party): Kátia Monte-Silva, Universidade Federal de Pernambuco

Tracking Information

• First Submitted Date: July 28, 2019
• First Posted Date: July 31, 2019
• Last Update Posted Date: August 16, 2019
• Estimated Study Start Date: September 2019
• Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2019)

Change in balance [ Time Frame: 5 minutes before the intervention and 10 minutes after the intervention ]

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.

Original Primary Outcome Measures (submitted: July 28, 2019)

Change in balance [ Time Frame: 5 minutes before the intervention and 10 minutes after the intervention ]

The change in balance will be assessed through postural control of biodex balance system

• Change History: Complete list of historical versions of study NCT04039048 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 13, 2019)

• Change in Ataxia' severity [ Time Frame: 10 minutes before the intervention and 15 minutes after the intervention ]
  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.
• Change in functional mobility [ Time Frame: 15 minutes before the intervention and 20 minutes after the intervention ]
  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.

Original Secondary Outcome Measures (submitted: July 28, 2019)

• Change in Ataxia' severity [ Time Frame: 10 minutes before the intervention and 15 minutes after the intervention ]
  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 mean more severe ataxia
• Change in functional mobility [ Time Frame: 15 minutes before the intervention and 20 minutes after the intervention ]
  The patient will walk 10 meters and the time will be mensured to determine the functional mobility

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of ctDCS During Balance Training on Cerebellar Ataxia
• Official Title: Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Cerebellar Ataxia
• Cerebellum; Injury
• Balance

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

Study Arms

• Experimental: ctDCS during Balance training
  Interventions:

  • Device: cerebellar transcranial direct current stimulation
  • Other: Balance training
• Sham Comparator: ctDCS sham during Balance training
  Interventions:

  • Device: Sham cerebellar transcranial direct current stimulation
  • Other: Balance training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 28, 2019): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2020
• Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kátia Monte-Silva, PhD; +55 81 2126-7579; monte.silvakk@gmail.com

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04039048
• Other Study ID Numbers: cerebellarataxia_balance_ctDCS
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Kátia Monte-Silva, Universidade Federal de Pernambuco
• Study Sponsor: Universidade Federal de Pernambuco
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidade Federal de Pernambuco
• Verification Date: August 2019