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

Not Applicable

• Conditions: Parkinson Disease; Gait Disorders, Neurologic; Parkinsonism; Parkinson; Gait, Festinating
• Interventions: Device: repetitive transcranial magnetic stimulation

• 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

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	repetitive transcranial magnetic 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)
Real Stimulation	repetitive transcranial magnetic 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.

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 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
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

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