Parkinson DiseaseDBSNCT04408573
Cycling Deep Brain Stimulation on Parkinson's Disease Gait
A study testing Cycling deep brain stimulation in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cycling deep brain stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Jun 2020to 29 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
- Hoehn \& Yahr stage between 2-4 during off-medication
- Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
- Willingness to comply with all study procedures
Who cannot join
- Active moderate/severe psychiatric condition
- Active infection or other uncontrolled moderate/grave comorbidities
- Treatment with experimental drug
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403000
Rubens G Cury, MD PhD, 55 11 26617877, rubens_cury@usp.br
Carina C França, MD
About this study
Official title: Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait
Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (>130Hz) stimulation, 2) cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
Read the detailed description
Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.
- Conditions
- Parkinson Disease
- Being tested
- Cycling deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling deep brain stimulationOther
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
| Study group | Role | What they receive |
|---|---|---|
| Regular Continuous High Frequency | No intervention | Patient remains 2 weeks in the currently chosen stimulation protocol. |
| Cycling High Frequency | Experimental | Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF Receives: Other: Cycling deep brain stimulation |
| Continuous Low Frequency | Experimental | Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol. Receives: Other: Cycling deep brain stimulation |
| Cycling Low Frequency | Experimental | Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol. Receives: Other: Cycling deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the part II of the Unified Parkinson's disease rating scale
The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.
Measured: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in the New Freezing of Gait Questionnaire
The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.
Measured: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Secondary outcomes (4)
Change in Falls Efficacy Scale
The Falls Efficacy Scale (FES) is a sixteen-item test rated on a 10-point scale from not confident at all to completely confident. It is correlated with difficulty getting up from a fall and level of anxiety. Scores vary from 16 - 64. Higher scores mean a worse outcome.
Measured: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in The Parkinson's Disease Questionnaire (PDQ-39)
This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure.Scores vary from 0 - 156. Higher scores mean a worse outcome.
Measured: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in Activities-Specific Balance Confidence Scale (ABC scale)
The ABC scale is a self-report measure of balance in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores vary from 0 - 100. Higher scores mean a better outcome.
Measured: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Number of falls
Patients will be questioned about number of times they experienced falls in the last 2 weeks. Higher numbers mean a worse outcome.
Measured: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start19 Jun 2020
- Primary completion29 May 2021 (estimated)
- Study completion29 Dec 2021 (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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- 2 weeks of regular continuous high frequency (\>130Hz) stimulation, 2 weeks of cycling high frequency (\>130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Gisbert Cury, University of Sao Paulo General Hospital
- Investigators
- Rubens G Cury, MD, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408573
- Sponsor's protocol ID
- 67914017.6.0000.0068
- Acronym
- DBS
- Status last verified
- Jun 2020
- First submitted
- 25 May 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait
- ClinicalTrials.gov ID
- NCT04408573
- Acronym / sponsor ID
- DBS / 67914017.6.0000.0068
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 29 May 2021 (estimated)
- Study completion
- 29 Dec 2021 (estimated)
- First posted
- 29 May 2020 (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.
Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (>130Hz) stimulation, 2) cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
Detailed description
Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 weeks of regular continuous high frequency (>130Hz) stimulation, 2 weeks of cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
| Arm | Type | Receives |
|---|---|---|
| Regular Continuous High Frequency | No intervention | –Patient remains 2 weeks in the currently chosen stimulation protocol. |
| Cycling High Frequency | Experimental | Other: Cycling deep brain stimulationPatient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF |
| Continuous Low Frequency | Experimental | Other: Cycling deep brain stimulationPatient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol. |
| Cycling Low Frequency | Experimental | Other: Cycling deep brain stimulationPatient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic Parkinson's disease
- Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
- Hoehn \& Yahr stage between 2-4 during off-medication
- Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
- Willingness to comply with all study procedures
Key exclusion criteria (4 listed)
- Active moderate/severe psychiatric condition
- Active infection or other uncontrolled moderate/grave comorbidities
- Treatment with experimental drug
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Cycling deep brain stimulationDeep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF | Other | Continuous Low Frequency, Cycling High Frequency, Cycling Low Frequency |
Primary outcome
Change in the part II of the Unified Parkinson's disease rating scale
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.
Change in the New Freezing of Gait Questionnaire
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.
4 secondary outcomes
Change in Falls Efficacy Scale
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in The Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in Activities-Specific Balance Confidence Scale (ABC scale)
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Number of falls
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Rubens G Cury, MD, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling deep brain stimulation in people with Parkinson Disease, run by University of Sao Paulo General Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens G Cury, MD, PhD (55 11 26617877, rubens_cury@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the part II of the Unified Parkinson's disease rating scale (time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks). The study lists 2 primary outcomes in all. 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 23 Jun 2020.