ParkinsonNCT04238000
Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease
A study testing repetitive transcranial magnetic stimulation in people with Parkinson and Parkinson Disease, run by Fondazione Europea di Ricerca Biomedica Ferb Onlus at 1 site in Italy.
Trial summary
Objective of the study: To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology Design: Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson, Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Jun 2020
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established Parkinson's disease
- ability to stand alone and walk without support
Who cannot join
- dementia or behavioral alterations
- contraindication to stimulation
Trial locations and contacts
1 site in 1 country.
Cristina Rizzetti contact
Italy1 site, 1 recruiting
- Recruiting
Parkinson's disease Rehabilitation Centre - FERB ONLUS
Trescore Balneario
Andrea Pilotto, MD, 3396245281 ext. 0039, pilottoandreae@gmail.com
Maria Cristina Rizzetti, MD, 035 955326, rizzetti@hotmail.com
About this study
Official title: Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease:a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.
Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology .
Read the detailed description
There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic stimulation
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Parkinson's disease patients able to walk and without dementia/behavioral disturbances will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.
Repetitive cerebellar theta burst stimulation will be performed by Duo-Mag XT100, using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.
A sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a total number of stimulation)
Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology.
Sensors assessment:
The following gait parameters will be evaluated in normal and cognitive/motor dual-tasks:
- step length ii) step variability iii) step phases iv) turning speed
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- repetitive Transcranial Magnetic stimulation, rTMS, wearing sensors, wearables, step variability, gait variability, gait speed, dual-task, dual-task walking, turning
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | Cerebellar Repetitive theta burst stimulation will be performed using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject. Receives: Device: repetitive transcranial magnetic stimulation |
| Sham Stimulation | Placebo comparator | The rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation) Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step variability in dual-task walking
Step variability will be assessed in normal, cognitive/motor dual-task conditions walking
Measured: Changes from Baseline to immediately after stimulation
Step length in dual-task walking
Step length will be assessed in normal, cognitive/motor dual-task conditions
Measured: Changes from Baseline to immediately after stimulation
Gait speed in dual-task walking
Gait speed will be assessed in normal, cognitive/motor dual-task conditions
Measured: Changes from Baseline to immediately after stimulation
Secondary outcomes (2)
Turning speed in timed up and go tests
Turning will be assessed y wearing sensors during timed up and go tests
Measured: Changes from Baseline to immediately after stimulation
total distance of dual-task walking
The total distance of one minute normal/motor/cognitive dual-task walking will be assessed
Measured: Changes from Baseline to immediately after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jan 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies 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
- Crossover
- Model description
- Each patient received both rTMS and sham cerebellar stimulation in randomized order in two different sessions, separated by at least 2 weeks. In each session, motor tasks, clinical scales and wearing sensor assessments were tested twice in all patients: at baseline (pre-stimulation) and after rTMS (post-stimulation)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel, Università degli Studi di Brescia
- Responsible party
- Principal investigator, Andrea Pilotto, Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Investigators
- Andrea Pilotto, MD, Principal investigator, FERB Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238000
- Sponsor's protocol ID
- 19/03
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The whole study will be published in medical journal
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease:a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology
- ClinicalTrials.gov ID
- NCT04238000
- Acronym / sponsor ID
- 19/03
- Keywords
- repetitive Transcranial Magnetic stimulation, rTMS, wearing sensors, wearables, step variability, gait variability, gait speed, dual-task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb OnlusUniversity, hospital or other
- Collaborators
- University of Kiel, Università degli Studi di Brescia
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 23 Jan 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.
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.
Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology .
Detailed description
There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic stimulation
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Parkinson's disease patients able to walk and without dementia/behavioral disturbances will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.
Repetitive cerebellar theta burst stimulation will be performed by Duo-Mag XT100, using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.
A sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a total number of stimulation)
Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology.
Sensors assessment:
The following gait parameters will be evaluated in normal and cognitive/motor dual-tasks:
- step length ii) step variability iii) step phases iv) turning speed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each patient received both rTMS and sham cerebellar stimulation in randomized order in two different sessions, separated by at least 2 weeks. In each session, motor tasks, clinical scales and wearing sensor assessments were tested twice in all patients: at baseline (pre-stimulation) and after rTMS (post-stimulation)
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Active comparator | Device: repetitive transcranial magnetic stimulationCerebellar Repetitive theta burst stimulation will be performed using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject. |
| Sham Stimulation | Placebo comparator | Device: repetitive transcranial magnetic stimulationThe rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- established Parkinson's disease
- ability to stand alone and walk without support
Key exclusion criteria (2 listed)
- dementia or behavioral alterations
- contraindication to stimulation
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationCerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description | Device | Real Stimulation, Sham Stimulation |
Primary outcome
Step variability in dual-task walking
Time frame: Changes from Baseline to immediately after stimulation
Step variability will be assessed in normal, cognitive/motor dual-task conditions walking
Step length in dual-task walking
Time frame: Changes from Baseline to immediately after stimulation
Step length will be assessed in normal, cognitive/motor dual-task conditions
Gait speed in dual-task walking
Time frame: Changes from Baseline to immediately after stimulation
Gait speed will be assessed in normal, cognitive/motor dual-task conditions
2 secondary outcomes
Turning speed in timed up and go tests
Time frame: Changes from Baseline to immediately after stimulation
total distance of dual-task walking
Time frame: Changes from Baseline to immediately after stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Yes. The whole study will be published in medical journal
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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.
Cristina Rizzetti contact
Andrea Pilotto, MD principal investigator
FERB Onlus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Parkinson and Parkinson Disease, run by Fondazione Europea di Ricerca Biomedica Ferb Onlus at 1 site in Italy.
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 2 inclusion and 2 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 Jan 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pilotto, MD (00393396245281, pilottoandreae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step variability in dual-task walking (time frame: Changes from Baseline to immediately after stimulation). The study lists 3 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 Jan 2020.