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Recruiting NCT07073287

Efficacy of Cerebello-spinal Direct Current Stimulation (csDCS) on Functional Mobility in Chronic Stroke Patients

Phase II Interventional Stroke Rehabilitation Gait Disorders, Neurologic tDCS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cerebello-spinal direct current stimulation, Sham Comparator.
Who it may be relevant to
Registry conditions: Stroke Rehabilitation, Gait Disorders, Neurologic, tDCS. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Cerebello-spinal Direct Current Stimulation on Functional Mobility in Chronic Stroke Patients

Overview

The aim of this clinical trial is to determine if cerebello-spinal direct current stimulation (csDCS) is effective in treating gait disorders in individuals with chronic stroke. Additionally, the trial seeks to evaluate the safety of this technique. The primary objectives include: Investigating whether cerebello-spinal direct current stimulation improves gait and functional mobility in participants with chronic stroke. Assessing any potential side effects associated with the method. Researchers will conduct a comparative analysis between cerebello-spinal direct current stimulation and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness in addressing gait disorders and enhancing mobility. Participants in the trial will: Undergo cerebello-spinal direct current stimulation combined with treadmill training or a sham procedure with treadmill training daily over a two-week period.

Interventions

  • Device Cerebello-spinal direct current stimulation
    csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.
  • Device Sham Comparator
    Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.

Primary outcome measures

  • Functional Mobility [Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days]
Secondary outcome measures (5)
  • Independency level [Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days]
  • Lower limb motor function [Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days]
  • Balance [Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days]
  • Perceived change in treatment [Time frame: Upon completion of the two-week intervention]
  • Spasticity [Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days]

Eligibility criteria

Inclusion criteria

  • Confirmation of Stroke by digital or physical imaging or medical report
  • Gait impairment
  • Stroke with at least 6 months after ictus

Exclusion criteria

  • Metallic implants in spinal cord
  • Major orthopedic/rheumatological disorders
  • Inability of verbal or non-verbal communication

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 3 centers
  • Federal University of Paraiba — João Pessoa
  • Federal University of Pernambuco — Recife
  • Federal University of Rio de Janeiro — Rio de Janeiro

Identifiers

NCT: NCT07073287 · csDCS_Stroke_Mobility

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗