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

NCT04238000 | Unknown

• 1 other identifier: 19/03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 .

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Turning speed in timed up and go tests

  Changes from Baseline to immediately after stimulation

• total distance of dual-task walking

  Changes from Baseline to immediately after stimulation

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

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.

Device: repetitive transcranial magnetic stimulation

Sham Stimulation

PLACEBO COMPARATOR

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)

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description

Real Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• dementia or behavioral alterations
• contraindication to stimulation

Sponsors & Collaborators

• Fondazione Europea di Ricerca Biomedica Ferb Onlus: lead
• University of Kiel: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (1)

Parkinson's disease Rehabilitation Centre - FERB ONLUS

Trescore Balneario, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Parkinsonian Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Andrea Pilotto, MD

  FERB Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Pilotto, MD

CONTACT

00393396245281; pilottoandreae@gmail.com

Cristina Rizzetti

CONTACT

rizzetti@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Parkinson's disease Rehabilitation Centre

Model Details: 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)

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: January 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: In the publication, within the next year
• Access Criteria: on line availability

Locations

IT (1)