Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in People With Parkinson's Disease

NCT04695496 | Unknown

• 1 other identifier: N202003057
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative disease. The cardinal symptoms of PD are tremor, rigidity, bradykinesia and postural instability. Gait disturbance is also one of the key features of PD. At present, the mainstream treatment of PD is the dopaminergic supplement. However, the response to the medical treatment varies between symptoms. Rigidity and bradykinesia respond to the medical treatment the best, and tremor respond partially. Gait disorders do not usually respond to the dopaminergic medication. Freezing of gait (FOG) is one of the most notorious and devastating presentation of gait disorders in PD. Currently, there is no available treatment for FOG, even the invasive deep brain stimulation does not work on it. Repetitive transcortical magnetic stimulation (rTMS) is a novel non-invasive intervention. Through the magnetic stimulation, brain neurons could be activated by the electrical current. The application of rTMS had been approved by US FDA for the treatment of depression. The possible effect of rTMS may result from the stimulation-related neuronal plasticity. Regarding PD, rTMS also had been found to had some effect on different motor symptoms, mainly on the bradykinesia and rigidity but not gait. The present study would like to test the accumulative effect of rTMS on gait disorders of PD, especially the phenomenon of FOG. All the study subjects will receive rTMS under intermittent theta burst stimulation (iTBS) mode at supplementary motor area (SMA). Gait analysis and other motor performance will be assessed before and after the intervention.

Conditions

Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (2)

• Change of duration on time up an go (TUG) test at 1 months later after theta burst stimulation

  Measurement change of duration on time up an go (TUG) test

  Baseline and 1 months later after theta burst stimulation

• Change of score on freezing of gait questionnaire (FOG-Q) at 1 months later after theta burst stimulation

  Measurement change of score on freezing of gait questionnaire (FOG-Q)

  Baseline and 1 months later after theta burst stimulation

Study Arms (1)

Theta bust stimulating group

EXPERIMENTAL

Theta burst stimulation with Magstim super rapid 2, over SMA. 3 section per day, for 5 days, total 15 sections.

Device: Theta bust stimulating

Interventions

Theta bust stimulating DEVICE

Theta burst stimulation with Magstim super rapid 2, over SMA. 3 section per day, for 5 days, total 15 sections.

Theta bust stimulating group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfill the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease, age between 45-80 years old.
• Can walk independently for 10 meters
• With FOG at either on or off period of time

You may not qualify if:

• \- People with
• pre-existing and active major neurological diseases other than PD
• with a previous history of seizures
• with implanted metallic objects that would contraindicate rTMS
• unable to perform fMRI
• with skin damage on the stimulation area
• with multiple sclerosis
• with large ischemic scars
• with a family history or medical history of seizures, epilepsy
• brain damage may affect the threshold for inducing epilepsy
• taken tricyclic antidepressants, analgesics, or anything that may lower the threshold for inducing epilepsy
• with sleep disorders during the rTMS treatment
• with severe alcohol abuse or use of epilepsy drugs
• with severe heart disease or uncontrollable migraine caused by high intracranial pressure
• who are actively suicidal during the trial period, have recurring major medical disorders, or with neurological co-morbidities such as space occupying lesions, CVA, aneurysms etc

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Tai Hong, MD, PHD

  Shuang Ho hospital, Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Chien-Tai Hong, MD, PHD

CONTACT

+886-2-22490088; ct.hong@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate of Medicine and of Philosophy

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)