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

F

Federal University of Health Science of Porto Alegre

Status

Not yet enrolling

Conditions

Spinocerebellar Ataxia - All Sub-types

Treatments

Device: transcranial direct current stimulation
Other: Neurofunctional Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06974149
FUHSPortoAlegreMarianaBrutto

Details and patient eligibility

About

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.

Full 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

Enrollment

15 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

15 participants in 2 patient groups

transcranial direct current stimulation associated with neurofunctional rehabilitation
Active Comparator group
Treatment:
Other: Neurofunctional Rehabilitation
Device: transcranial direct current stimulation
Other: Neurofunctional Rehabilitation
Device: transcranial direct current stimulation
transcranial direct current stimulation simulated associated with neurofunctional rehabilitation
Sham Comparator group
Treatment:
Other: Neurofunctional Rehabilitation
Device: transcranial direct current stimulation
Other: Neurofunctional Rehabilitation
Device: transcranial direct current stimulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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