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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238000
• Other study ID #: 19/03
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2020
• Source: Fondazione Europea di Ricerca Biomedica Ferb Onlus
• Contact: Andrea Pilotto, MD
• Phone: 00393396245281
• Email: pilottoandreae[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• established Parkinson's disease

• ability to stand alone and walk without support

Exclusion Criteria:

• dementia or behavioral alterations

• contraindication to stimulation

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Festinating
• Nervous System Diseases
• Parkinson
• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

Device:
• repetitive transcranial magnetic stimulation
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description

Locations

Country	Name	City	State
Italy	Parkinson's disease Rehabilitation Centre - FERB ONLUS	Trescore Balneario

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Europea di Ricerca Biomedica Ferb Onlus	Università degli Studi di Brescia, University of Kiel

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step variability in dual-task walking	Step variability will be assessed in normal, cognitive/motor dual-task conditions walking	Changes from Baseline to immediately after stimulation
Primary	Step length in dual-task walking	Step length will be assessed in normal, cognitive/motor dual-task conditions	Changes from Baseline to immediately after stimulation
Primary	Gait speed in dual-task walking	Gait speed will be assessed in normal, cognitive/motor dual-task conditions	Changes from Baseline to immediately after stimulation
Secondary	Turning speed in timed up and go tests	Turning will be assessed y wearing sensors during timed up and go tests	Changes from Baseline to immediately after stimulation
Secondary	total distance of dual-task walking	The total distance of one minute normal/motor/cognitive dual-task walking will be assessed	Changes from Baseline to immediately after stimulation