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Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia

NCT06267222 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-06-10

No results posted yet for this study

Summary

The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are:

* If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol.
* If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions.

* Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges.
* Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6).

Conditions

  • SCA
  • Postural Balance
  • Gait Ataxia

Interventions

DEVICE

TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises

Participants with SCA will receive trans-spinal tDCS and exercises. There will be no control group or sham stimulation. All participants will receive real tDCS stimulation

Sponsors & Collaborators

  • Federal Institute of Rio de Janeiro

    collaborator OTHER

  • Laura Alice Santos de Oliveira

    lead OTHER

Principal Investigators

  • LAURA OLIVEIRA, PT PHD · Centro Universitário Augusto Motta

  • ANNA FONTES BAPTISTA, PT · Centro Universitário Augusto Motta

  • Eduardo S Moreira, PT · Centro Universitário Augusto Motta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2024-06-30
Completion
2024-07-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267222 on ClinicalTrials.gov