Clinical trial NCT04238000: Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Parkinson Disease
Gait Disorders, Neurologic
Parkinsonism
Gait, Festinating
Keywords: repetitive Transcranial Magnetic stimulation
rTMS
wearing sensors
wearables
step variability
gait variability
gait speed
dual-task
dual-task walking
turning
Lead sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus
Sponsor class: OTHER
Collaborators: name: University of Kiel
name: Università degli Studi di Brescia
First posted: 2020-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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)
Primary purpose: TREATMENT

Brief 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. 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:

i) step length ii) step variability iii) step phases iv) turning speed

Eligibility criteria: Inclusion Criteria:

* established Parkinson's disease
* ability to stand alone and walk without support

Exclusion Criteria:

* dementia or behavioral alterations
* contraindication to stimulation

Primary outcomes:
measure: Step variability in dual-task walking
timeFrame: Changes from Baseline to immediately after stimulation
measure: Step length in dual-task walking
timeFrame: Changes from Baseline to immediately after stimulation
measure: Gait speed in dual-task walking
timeFrame: Changes from Baseline to immediately after stimulation
Secondary outcomes:
measure: Turning speed in timed up and go tests
timeFrame: Changes from Baseline to immediately after stimulation
measure: total distance of dual-task walking
timeFrame: Changes from Baseline to immediately after stimulation
Other outcomes:
Locations:
city: Trescore Balneario
country: Italy
facility: Parkinson's disease Rehabilitation Centre - FERB ONLUS
Study officials:
affiliation: FERB Onlus
name: Andrea Pilotto, MD
role: PRINCIPAL_INVESTIGATOR
References: