Stroke RehabilitationPhase 2NCT07073287
Efficacy of Cerebello-spinal Direct Current Stimulation (csDCS) on Functional Mobility in Chronic Stroke Patients
A Phase 2 study testing Cerebello-spinal direct current stimulation in people with Stroke Rehabilitation and Gait Disorders, Neurologic, run by Universidade Federal de Pernambuco at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke Rehabilitation, Gait Disorders, Neurologic, tDCS
- What is being tested?
- Cerebello-spinal direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 May 2024to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of Stroke by digital or physical imaging or medical report
- Gait impairment
- Stroke with at least 6 months after ictus
Who cannot join
- Metallic implants in spinal cord
- Major orthopedic/rheumatological disorders
- Inability of verbal or non-verbal communication
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil3 sites, 3 recruiting
- Recruiting
Federal University of Paraiba
João Pessoa, Paraíba, 58051-900
Mayza Felix, Bachelor in physical therapy, 8199207653 ext. +55, mayzaleite@gmail.com
- Recruiting
Federal University of Pernambuco
Recife, Pernambuco, 50670-420
DANIEL G MELO, Bachelor in physical therapy, 81995173332 ext. + 55, gmelodaniel@gmail.com
- Recruiting
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 23510-220
Ana P Fontana, PhD in biophysics, 21 997651800 ext. +55, fontanaap@gmail.com
About this study
Official title: Efficacy of Cerebello-spinal Direct Current Stimulation 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:
Read more
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
- Being tested
- Cerebello-spinal direct current stimulation, Sham Comparator
- Keywords
- spinal cord, stroke, gait, rehabilitation, direct current stimulation
- Medical subject headings
- Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebello-spinal direct current stimulationDevice
Also called csDCS
csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.
Sham ComparatorDevice
Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.
| Study group | Role | What they receive |
|---|---|---|
| Active cerebello-spinal direct current stimulation | Experimental | csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes. Receives: Device: Cerebello-spinal direct current stimulation |
| Sham cerebello-spinal direct current stimulation | Sham comparator | Treadmill training with masking for cerebello-spinal direct current stimulation Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-treatment (2 weeks) and follow up after 30 days
Secondary outcomes (5)
Independency level
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).
Measured: Baseline, post-treatment (2 weeks) and follow up after 30 days
Lower limb motor function
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).
Measured: Baseline, post-treatment (2 weeks) and follow up after 30 days
Balance
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.
Measured: Baseline, post-treatment (2 weeks) and follow up after 30 days
Perceived change in treatment
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.
Measured: Upon completion of the two-week intervention
Spasticity
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.
Measured: Baseline, post-treatment (2 weeks) and follow up after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 May 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073287
- Sponsor's protocol ID
- csDCS_Stroke_Mobility
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cerebello-spinal Direct Current Stimulation on Functional Mobility in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07073287
- Acronym / sponsor ID
- csDCS_Stroke_Mobility
- Conditions
- Stroke Rehabilitation, Gait Disorders, Neurologic, tDCS
- Keywords
- spinal cord, stroke, gait, rehabilitation, direct current stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active cerebello-spinal direct current stimulation | Experimental | Device: Cerebello-spinal direct current stimulationcsDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes. |
| Sham cerebello-spinal direct current stimulation | Sham comparator | Device: Sham ComparatorTreadmill training with masking for cerebello-spinal direct current stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmation of Stroke by digital or physical imaging or medical report
- Gait impairment
- Stroke with at least 6 months after ictus
Key exclusion criteria (3 listed)
- Metallic implants in spinal cord
- Major orthopedic/rheumatological disorders
- Inability of verbal or non-verbal communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebello-spinal direct current stimulationAlso: csDCScsDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes. | Device | Active cerebello-spinal direct current stimulation |
| Sham ComparatorMasking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation. | Device | Sham cerebello-spinal direct current stimulation |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cerebello-spinal direct current stimulation in people with Stroke Rehabilitation and Gait Disorders, Neurologic, run by Universidade Federal de Pernambuco at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DANIEL MELO, Bachelor in physical therapy (81995173332 ext. +55, gmelodaniel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Mobility (time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.