Parkinson DiseaseNCT06856941
CsDCS on Functional Mobility in Parkinsons Disease
A study testing cerebello-spinal direct current stimulation in people with Parkinson Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- 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
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 9 May 2024to Mar 2026
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a clinical diagnosis of PD provided by a neurologist
- regular dopaminergic drug treatment (at least three months of use)
- aged 40 years or over
- staging I to IV on the modified Hoehn and Yahr scale
Who cannot join
- other neurological disorders, postural hypotension, vestibular, musculoskeletal or visual disorders that compromise performance in the proposed tests
- other osteoarticular diseases in the lower limbs that interfere with performance and locomotion
- a Montreal Cognitive Assessment (MoCA) score of less than 21 points
- have undergone previous surgery for PD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740-560
João Fabrício
About this study
Official title: Cerebello-spinal Direct Current Stimulation Associated with Treadmill Gait Training in Functional Mobility in Patients with Parkinsons Disease
Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.
- Conditions
- Parkinson Disease
- Being tested
- cerebello-spinal direct current stimulation, sham cerebello-spinal direct current stimulation
- Keywords
- gait training, parkinson disease, functional mobility, csDCS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebello-spinal direct current stimulationDevice
Cerebello-spinal direct current stimulation is an electrical stimulus in the cerebellum as well as in the spinal cord that is used to improve functional mobility. To our knowledge, this is the first study to use this setup in individuals with Parkinsons disease.
sham cerebello-spinal direct current stimulationDevice
Sham cerebello-spinal direct current stimulation involves masking, where the total duration of stimulation is thirty seconds, which is sufficient to mimic the sensation of stimulation but without neuromodulatory effects
| Study group | Role | What they receive |
|---|---|---|
| csDCS | Active comparator | Not described Receives: Device: cerebello-spinal direct current stimulation |
| csDCS sham | Sham comparator | Not described Receives: Device: sham cerebello-spinal direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
For the TUG, the time taken by the patient to perform a task involving standing up from a chair, walking, and sitting back down is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up, walks three meters at their fastest yet safe pace, turns around, returns to the chair, and sits down. Shorter times in completing this task indicate better functional mobility. Three repetitions of the test were recorded, and for analysis purposes, the average of the repetitions was used.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (5)
Five times sit to stand test
For the TSL5, the time taken by the patient to perform the task of sitting and standing from a chair five times consecutively is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up and sits down five times at their fastest pace, but safely. Shorter times on this test indicate better functional mobility. The average of three attempts was used as the final result.
Measured: From enrollment to the end of treatment at 4 weeks
Mini balance evaluation system test
The abbreviated version of the Balance Evaluation System Test (miniBESTest) assesses static and dynamic balance through six different balance control mechanisms based on 14 specific activities of daily living. Each activity is rated from 0 (worst performance) to 2 (best performance) points. Thus, lower scores indicate poorer balance.
Measured: From enrollment to the end of treatment at 4 weeks
Unified Parkinson Disease Rating Scale-II and Scale-III
The motor function of the patients was assessed using the Unified Parkinsons Disease Rating Scale (UPDRS). The UPDRS is the most widely used clinical assessment tool for characterizing the motor symptoms of Parkinsons disease and for monitoring the progression of these symptoms and the physical disability caused by the disease. The UPDRS consists of 50 items, each rated from 0 to 4, ranging from the best (0) to the worst motor performance (4), and it is widely accepted for determining the efficacy of interventions in clinical studies. In the present study, Section II was used, which refers to the severity of the disease concerning the performance of activities of daily living. This section includes 13 items, each scored from 0 to 4, from the best to the greatest impairment. Section III of the UPDRS was also used, which corresponds to the motor examination and measures: resting tremor, postural tremor, rigidity, speech, facial expression, chair rise, posture, gait, postural stability
Measured: From enrollment to the end of treatment at 4 weeks
Freezing of gait questionnaire
The Freezing of Gait Questionnaire (FOG-Q) is a scale that assesses the individual's subjective perception of the severity and impact of freezing on their gait performance. The FOG-Q is classified on a 5-point scale (0 to 4), with a total score ranging from 0 to 24. A higher score indicates that the individual's gait performance is more affected by freezing.
Measured: From enrollment to the end of treatment at 4 weeks
Six minute walking test
In the 6MWT, the patient walks at their fastest, yet safe, pace along a 30-meter straight path for six minutes. At the end of the test, the total distance covered is calculated. Greater distances indicate better functional mobility.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start9 May 2024
- Primary completionJul 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, Study director, Universidade Federal de PernambucoJoão Fabrício, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856941
- Sponsor's protocol ID
- 78055423.8.1001.5208
- Status last verified
- Dec 2024
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebello-spinal Direct Current Stimulation Associated with Treadmill Gait Training in Functional Mobility in Patients with Parkinsons Disease
- ClinicalTrials.gov ID
- NCT06856941
- Acronym / sponsor ID
- 78055423.8.1001.5208
- Conditions
- Parkinson Disease
- Keywords
- gait training, parkinson disease, functional mobility, csDCS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 Mar 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.
Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| csDCS | Active comparator | Device: cerebello-spinal direct current stimulation |
| csDCS sham | Sham comparator | Device: sham cerebello-spinal direct current stimulation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a clinical diagnosis of PD provided by a neurologist
- regular dopaminergic drug treatment (at least three months of use)
- aged 40 years or over
- staging I to IV on the modified Hoehn and Yahr scale
Key exclusion criteria (4 listed)
- other neurological disorders, postural hypotension, vestibular, musculoskeletal or visual disorders that compromise performance in the proposed tests
- other osteoarticular diseases in the lower limbs that interfere with performance and locomotion
- a Montreal Cognitive Assessment (MoCA) score of less than 21 points
- have undergone previous surgery for PD
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 stimulationCerebello-spinal direct current stimulation is an electrical stimulus in the cerebellum as well as in the spinal cord that is used to improve functional mobility. To our knowledge, this is the first study to use this setup in individuals with Parkinsons disease. | Device | csDCS |
| sham cerebello-spinal direct current stimulationSham cerebello-spinal direct current stimulation involves masking, where the total duration of stimulation is thirty seconds, which is sufficient to mimic the sensation of stimulation but without neuromodulatory effects | Device | csDCS sham |
Primary outcome
Timed Up and Go
Time frame: From enrollment to the end of treatment at 4 weeks
For the TUG, the time taken by the patient to perform a task involving standing up from a chair, walking, and sitting back down is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up, walks three meters at their fastest yet safe pace, turns around, returns to the chair, and sits down. Shorter times in completing this task indicate better functional mobility. Three repetitions of the test were recorded, and for analysis purposes, the average of the repetitions was used.
5 secondary outcomes
Five times sit to stand test
Time frame: From enrollment to the end of treatment at 4 weeks
Mini balance evaluation system test
Time frame: From enrollment to the end of treatment at 4 weeks
Unified Parkinson Disease Rating Scale-II and Scale-III
Time frame: From enrollment to the end of treatment at 4 weeks
Freezing of gait questionnaire
Time frame: From enrollment to the end of treatment at 4 weeks
Six minute walking test
Time frame: From enrollment to the end of treatment at 4 weeks
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 4 Mar 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.
Kátia Monte-Silva study director
Universidade Federal de Pernambuco
João Fabrício principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebello-spinal direct current stimulation in people with Parkinson Disease, run by Universidade Federal de Pernambuco at 1 site 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 4 inclusion and 4 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Kátia Monte-Silva (5581986450112, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (time frame: From enrollment to the end of treatment at 4 weeks). 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 4 Mar 2025; AzTrials last refreshed its copy on 5 Nov 2026.