Clinical trial NCT06974149: Effects of Transcranial Direct Current Stimulation Associated With Neurofunctional Rehabilitation in Individuals With Spinocerebellar Ataxias
Official title: The Effects of Transcranial Direct Current Stimulation Associated With Neurofunctional Rehabilitation in Individuals With Spinocerebellar Ataxias - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinocerebellar Ataxia - All Sub-types
Keywords: spinocerebellar ataxias; transcranial direct current stimulation; neurological rehabilitation.
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Secondary outcomes:
measure: Mini-BEST test
timeFrame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
measure: Stabilometry
timeFrame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
measure: Timed Up and Go (TUG)
timeFrame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
measure: 8-meter walk test (8mWT)
timeFrame: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
measure: Gait analysis
timeFrame: baseline, at the end of 5,10 and 20 sessions e follow up ( 2 and 4 months)
measure: Form Health Survey 36 (SF-36)
timeFrame: baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)
Other outcomes:
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