The Effect of Repetitive Transcranial Magnetic Stimulation on the Cognition in People With Parkinson's Disease

NCT04698928 | Unknown

• 1 other identifier: N202004024
• 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. Cognitive impairment and dementia are also one of the key features of the non-motor symptoms of PD. At present, the mainstream treatment of PD-dementia is the dopaminergic rivastigmine. 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 and cognition. The present study would like to test the accumulative effect of rTMS on cognition of PD. All the study subjects will receive rTMS under intermittent theta burst stimulation (iTBS) mode at supplementary motor area (SMA). Cognitive bahevorial tests and other motor/depression assessments will be assessed before and after the intervention.

Conditions

Parkinson Disease With Dementia

Outcome Measures

Primary Outcomes (5)

• Change from baseline Mini-Mental State Examination (MMSE) score at 1 months after theta burst stimulation

  Measure score change on Mini-Mental State Examination. The maximum score is 30 and the minimum score is 0, with higher score means better outcome.

  Baseline and 1 months after theta burst stimulation

• Change from baseline Wechsler Memory Scale (WMS) score at 1 months after theta burst stimulation

  Measure score change on Wechsler Memory Scale (WMS). Higher score means better outcome.

  Baseline and 1 months after theta burst stimulation

• Change from baseline Trial Making Test A and B at 1 months after theta burst stimulation

  Measure score change on Trial Making Test A and B

  Baseline and 1 months after theta burst stimulation

• Change from baseline Category Fluency Test at 1 months after theta burst stimulation

  Measure score change on Category Fluency Test

  Baseline and 1 months after theta burst stimulation

• Change from baseline Clock Drawing Test at 1 months after theta burst stimulation

  Measure score change on Clock Drawing Test

  Baseline and 1 months after theta burst stimulation

Study Arms (1)

Theta burst stimulation group

EXPERIMENTAL

Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.

Device: Theta burst stimulation

Interventions

Theta burst stimulation DEVICE

Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.

Theta burst stimulation 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.
• With mild cognitive impairment or dementia (Clinical Dementia Rating Scale \>= 0.5)

You may not qualify if:

• \- People who have
• 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

Study Officials

• Chien-Tai Chien-Tai, MD, PHD

  Shuang Ho hospital, Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Chien-Tai Chien-Tai, 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: Attending physician, Associate Professor

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: January 7, 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)