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

NCT07073287 | Recruiting Phase 2

• 1 other identifier: csDCS_Stroke_Mobility
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stroke Rehabilitation; Gait Disorders, Neurologic; tDCS

Keywords

spinal cord; stroke; gait; rehabilitation; direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Functional Mobility

  The Timed-Up and Go (TUG) test is used to evaluate an individual´s capacity to stand up, walk, and sit down. During the test, the participants are timed from the moment they begin to stand up until they are seated again.

  Baseline, post-treatment (2 weeks) and follow up after 30 days

Secondary Outcomes (5)

• Independency level

  Baseline, post-treatment (2 weeks) and follow up after 30 days

• Lower limb motor function

  Baseline, post-treatment (2 weeks) and follow up after 30 days

• Balance

  Baseline, post-treatment (2 weeks) and follow up after 30 days

• Perceived change in treatment

  Upon completion of the two-week intervention

• Spasticity

  Baseline, post-treatment (2 weeks) and follow up after 30 days

Study Arms (2)

Active cerebello-spinal direct current stimulation

EXPERIMENTAL

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

Device: Cerebello-spinal direct current stimulation

Sham cerebello-spinal direct current stimulation

SHAM COMPARATOR

Treadmill training with masking for cerebello-spinal direct current stimulation

Device: Sham Comparator

Interventions

Cerebello-spinal direct current stimulation DEVICE

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

Also known as: csDCS

Active cerebello-spinal direct current stimulation

Sham Comparator DEVICE

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

Sham cerebello-spinal direct current stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Universidade Federal do Rio de Janeiro: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (3)

Federal University of Paraiba

João Pessoa, Paraíba, 58051-900, Brazil

RECRUITING

Federal University of Pernambuco

Recife, Pernambuco, 50670-420, Brazil

RECRUITING

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 23510-220, Brazil

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

DANIEL MELO, Bachelor in physical therapy

CONTACT

81995173332; gmelodaniel@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 18, 2025
• Study Start: May 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

BR (3)