Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease
NCT ID: NCT04238000
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-01-01
2020-06-01
Brief Summary
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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 .
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Detailed Description
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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:
i) step length ii) step variability iii) step phases iv) turning speed
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Real Stimulation
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.
repetitive transcranial magnetic stimulation
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Sham Stimulation
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)
repetitive transcranial magnetic stimulation
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Interventions
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repetitive transcranial magnetic stimulation
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Eligibility Criteria
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Inclusion Criteria
* ability to stand alone and walk without support
Exclusion Criteria
* contraindication to stimulation
40 Years
85 Years
ALL
No
Sponsors
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University of Kiel
OTHER
Università degli Studi di Brescia
OTHER
Fondazione Europea di Ricerca Biomedica Ferb Onlus
OTHER
Responsible Party
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Andrea Pilotto
Parkinson's disease Rehabilitation Centre
Principal Investigators
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Andrea Pilotto, MD
Role: PRINCIPAL_INVESTIGATOR
FERB Onlus
Locations
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Parkinson's disease Rehabilitation Centre - FERB ONLUS
Trescore Balneario, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19/03
Identifier Type: -
Identifier Source: org_study_id
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