Effects of Transcranial Direct Current Stimulation Associated With Neurofunctional Rehabilitation in Individuals With Spinocerebellar Ataxias

NCT ID: NCT06974149

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2029-02-28

Brief Summary

The aim of this study is to evaluate the effects of . Transcranial direct current stimulation (tDCS) combined with neurofunctional rehabilitation on disease severity in individuals with neurodegenerative ataxias. The study will compare whether the Neurofunctional Rehabilitation Protocol combined with real tDCS will bring better results in reducing disease severity compared to the neurofunctional rehabilitation protocol combined with simulated tDCS.

Detailed Description

Neurodegenerative ataxias are a group of heterogeneous and progressive diseases that affect the cerebellum. Symptoms related to these diseases include difficulties with walking, balance, and motor coordination. Neurofunctional rehabilitation can help improve these motor symptoms. However, it is still limited in reducing neurodegeneration. Transcranial direct current stimulation (tDCS) applied to the cerebellum has shown to be a promising treatment in reducing disease severity, improving balance, and improving the quality of life of these individuals. tDCS in combination with neurofunctional rehabilitation may be a beneficial alternative in neurodegenerative ataxias, but studies are lacking. Regarding neurofunctional rehabilitation, some studies have shown improvements in reducing the progression of this pathology. However, as a rule, these studies presented poorly detailed protocols. Furthermore, the study populations included several types of cerebellar ataxias. Therefore, a detailed description of physiotherapy exercises, also recording them in images, with a more homogeneous sample, can ensure the viability of a more efficient treatment. tDCS applied to ataxia, in turn, presented beneficial results regarding disease progression, walking speed, balance and, also, quality of life. tDCS can enhance the effects of neurofunctional rehabilitation, as has already been proven in other populations. The combination of tDCS with neurofunctional rehabilitation is still poorly described in the literature in patients with neurodegenerative ataxias. Therefore, it is necessary to conduct a study specifically designed to test the hypothesis that tDCS combined with neurofunctional rehabilitation will demonstrate better results in relation to disease severity, postural control, risk of falls, quality of life and fatigue. In this case, a ten-session protocol can be applied, evaluating the results in 5 (five) ,10 (ten) and 20 (twenty)sessions, positioning the anode in the cerebellum and the cathode in the spinal cord, with patient monitoring for 16 (sixteen) weeks. This study can, finally, compare the results between neurofunctional rehabilitation combined with tDCS and neurofunctional rehabilitation alone

Conditions

Spinocerebellar Ataxia - All Sub-types

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

transcranial direct current stimulation associated with neurofunctional rehabilitation

Group Type: ACTIVE_COMPARATOR

Neurofunctional Rehabilitation

Intervention Type: OTHER

Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs

transcranial direct current stimulation

Intervention Type: DEVICE

Transcranial direct current stimulation will be applied for 20 minutes at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11)

transcranial direct current stimulation simulated associated with neurofunctional rehabilitation

Group Type: SHAM_COMPARATOR

Neurofunctional Rehabilitation

Intervention Type: OTHER

Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs

transcranial direct current stimulation

Intervention Type: DEVICE

Transcranial direct current stimulation will be applied for 30 seconds at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11). However the electrodes will be kept for 20 minutes to mask the stimulation

Interventions

Neurofunctional Rehabilitation

Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs

Intervention Type: OTHER

transcranial direct current stimulation

Transcranial direct current stimulation will be applied for 20 minutes at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11)

Intervention Type: DEVICE

Neurofunctional Rehabilitation

Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs

Intervention Type: OTHER

transcranial direct current stimulation

Transcranial direct current stimulation will be applied for 30 seconds at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11). However the electrodes will be kept for 20 minutes to mask the stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of spinocerebellar ataxias;
• Walking independently or with aids;

Exclusion Criteria

• Metal implants in the brain or spinal column and Cochlear implants;
• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Cechetti

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FUHSPortoAlegreMarianaBrutto

Identifier Type: -

Identifier Source: org_study_id