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

NCT ID: NCT07073287

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Rehabilitation Gait Disorders, Neurologic tDCS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial, double blinded (therapist/evaluator, patient) Initial evaluation, followed by 10 days of treatment, followed by a re-evaluation immediately after and follow-up 30 days after finishing.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active cerebello-spinal direct current stimulation

csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.

Group Type EXPERIMENTAL

Cerebello-spinal direct current stimulation

Intervention Type DEVICE

csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.

Sham cerebello-spinal direct current stimulation

Treadmill training with masking for cerebello-spinal direct current stimulation

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type DEVICE

Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.

Interventions

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Cerebello-spinal direct current stimulation

csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.

Intervention Type DEVICE

Sham Comparator

Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.

Intervention Type DEVICE

Other Intervention Names

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csDCS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Paraiba

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Site Status RECRUITING

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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DANIEL MELO, Bachelor in physical therapy

Role: CONTACT

81995173332 ext. +55

Facility Contacts

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Mayza Felix, Bachelor in physical therapy

Role: primary

8199207653 ext. +55

DANIEL G MELO, Bachelor in physical therapy

Role: primary

81995173332 ext. + 55

Ana P Fontana, PhD in biophysics

Role: primary

21 997651800 ext. +55

Other Identifiers

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csDCS_Stroke_Mobility

Identifier Type: -

Identifier Source: org_study_id

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