Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease; Gait Disorders, Neurologic; Parkinsonism; Parkinson; Gait, Festinating

• Registration Number: NCT04238000
• Lead Sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus

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

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-18
• Last Update Submitted: 2020-01-18
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23
• Primary Completion: 2020-04-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• dementia or behavioral alterations
• contraindication to stimulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gait speed in dual-task walking	Changes from Baseline to immediately after stimulation	Gait speed will be assessed in normal, cognitive/motor dual-task conditions
Step length in dual-task walking	Changes from Baseline to immediately after stimulation	Step length will be assessed in normal, cognitive/motor dual-task conditions
Step variability in dual-task walking	Changes from Baseline to immediately after stimulation	Step variability will be assessed in normal, cognitive/motor dual-task conditions walking

Secondary Outcome Measures

Name	Time	Method
Turning speed in timed up and go tests	Changes from Baseline to immediately after stimulation	Turning will be assessed y wearing sensors during timed up and go tests
total distance of dual-task walking	Changes from Baseline to immediately after stimulation	The total distance of one minute normal/motor/cognitive dual-task walking will be assessed

Trial Locations

Locations (1)

Parkinson's disease Rehabilitation Centre - FERB ONLUS; 🇮🇹 Trescore Balneario, Italy