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

Primary Purpose

Parkinson, Parkinson Disease, Gait Disorders, Neurologic

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
Fondazione Europea di Ricerca Biomedica Ferb Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson focused on measuring repetitive Transcranial Magnetic stimulation, rTMS, wearing sensors, wearables, step variability, gait variability, gait speed, dual-task, dual-task walking, turning

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • dementia or behavioral alterations
  • contraindication to stimulation

Sites / Locations

  • Parkinson's disease Rehabilitation Centre - FERB ONLUSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Real Stimulation

Sham Stimulation

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

Step variability in dual-task walking
Step variability will be assessed in normal, cognitive/motor dual-task conditions walking
Step length in dual-task walking
Step length will be assessed in normal, cognitive/motor dual-task conditions
Gait speed in dual-task walking
Gait speed will be assessed in normal, cognitive/motor dual-task conditions

Secondary Outcome Measures

Turning speed in timed up and go tests
Turning will be assessed y wearing sensors during timed up and go tests
total distance of dual-task walking
The total distance of one minute normal/motor/cognitive dual-task walking will be assessed

Full Information

First Posted
January 18, 2020
Last Updated
January 18, 2020
Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
University of Kiel, Università degli Studi di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT04238000
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
University of Kiel, Università degli Studi di Brescia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
ParticipantInvestigator
Masking Description
The patient and the examiner who administered the clinical scales were blind to the type of rTMS delivered, which was applied by another blinded experimenter.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Stimulation
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Primary Outcome Measure Information:
Title
Step variability in dual-task walking
Description
Step variability will be assessed in normal, cognitive/motor dual-task conditions walking
Time Frame
Changes from Baseline to immediately after stimulation
Title
Step length in dual-task walking
Description
Step length will be assessed in normal, cognitive/motor dual-task conditions
Time Frame
Changes from Baseline to immediately after stimulation
Title
Gait speed in dual-task walking
Description
Gait speed will be assessed in normal, cognitive/motor dual-task conditions
Time Frame
Changes from Baseline to immediately after stimulation
Secondary Outcome Measure Information:
Title
Turning speed in timed up and go tests
Description
Turning will be assessed y wearing sensors during timed up and go tests
Time Frame
Changes from Baseline to immediately after stimulation
Title
total distance of dual-task walking
Description
The total distance of one minute normal/motor/cognitive dual-task walking will be assessed
Time Frame
Changes from Baseline to immediately after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Pilotto, MD
Phone
00393396245281
Email
pilottoandreae@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Rizzetti
Email
rizzetti@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pilotto, MD
Organizational Affiliation
FERB Onlus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkinson's disease Rehabilitation Centre - FERB ONLUS
City
Trescore Balneario
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Pilotto, MD
Phone
3396245281
Ext
0039
Email
pilottoandreae@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Cristina Rizzetti, MD
Phone
035 955326
Email
rizzetti@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The whole study will be published in medical journal
IPD Sharing Time Frame
In the publication, within the next year
IPD Sharing Access Criteria
on line availability

Learn more about this trial

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

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