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NCT Number: NCT07073287

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Paraiba, João Pessoa, Paraíba, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cerebello-spinal direct current stimulation

Device

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

Other names: csDCS

Sham Comparator

Device

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

Primary outcomes

  1. Functional Mobility

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

    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.

Secondary outcomes

  1. Independency level

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

    Self-reported independence is assessed using the Functional Ambulation Categories (FAC). Scores range from 0 (inability to walk even with external help) to 5 (normal ambulation).

  2. Lower limb motor function

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

    Motor function of the lower limbs is assessed using the Fugl-Meyer Assessment, where scores range from 0 (indicating the worst motor function) to 28 (indicating normal motor function).

  3. Balance

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

    Capacity to maintain balance during various tasks is assessed using the Mini Balance Evaluation System (MiniBEST-test). Its scores range from 0 to 28 points. Lower scores indicate poor balance, while higher scores reflect better balance.

  4. Perceived change in treatment

    Time frame: Upon completion of the two-week intervention

    Evaluation of how the participant describe the perceived change in their condition since the treatment started, using the Patient Global Impression of Change (PGM). This scale assesses the change in activity limitations, symptoms, emotions, and overall quality of life since the beginning of treatment, ranging from no change or worsening to significant improvement that made a considerable difference. A score of one indicates no change, while a score of seven represents a substantial improvement.

  5. Spasticity

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

    Muscle tone disorders will be assessed using the Modified Ashworth Scale, which measures spasticity by grading muscle resistance during passive stretching. The scale ranges from 0 to 4, where 0 indicates no increase in muscle tone, and 4 represents a limb that is rigid in flexion or extension.

Study contacts

Contact information is provided by the study sponsor or research team.

DANIEL MELO, Bachelor in physical therapy

CONTACT

[email protected]

81995173332 ext. +55

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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