Clinical trial NCT04804176: Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
Official title: Study on the Mode and Mechanism of Ultra-low Frequency Repetitive Transcranial Magnetic Stimulation for Sleep Disorders in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Repetitive Transcranial Magnetic Stimulation
Parkinson Disease
Sleep Disorder
Keywords: repetitive transcranial magnetic stimulation
Parkinson's disease
sleep disorder
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was divided into three groups, which were control group, group A and group B.Groups A and B received different treatment modalities on the same device.
Primary purpose: TREATMENT

Brief summary: The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.

Detailed description: Parkinson's disease is the second most common chronic neurodegenerative disease.At present, researchers focus not only on the motor symptoms of Parkinson's disease, but also on the non-motor symptoms of Parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).The principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by Faraday. When an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.

Eligibility criteria: Inclusion Criteria:

* in line with international Movement disorders association (the Movement Disorder Society, MDS) in 2015 the diagnosis of Parkinson's disease diagnosis standard and China standard (2016)
* can cooperate to complete rating scale, the sleep monitoring, imaging and blood test
* have a sleep disorder
* aged 18 to 70 years old
* agree to participate in this experiment, and have signed the informed consent

Exclusion Criteria:

* superposition of diagnosed with Parkinson's syndrome
* secondary diagnosed Parkinson's syndrome
* is equipped with heart pacemakers and other metal implants
* cannot achieve scale assessment
* has significant malignant diseases
* has a history of seizures

Primary outcomes:
measure: change from length of sleep at one week
timeFrame: one week
measure: change from ratio of stage 3 sleep in total sleep at one week
timeFrame: one week
measure: change from limb movement of sleep at one week
timeFrame: one week
measure: change from nocturnal arousal frequency at one week
timeFrame: one week
measure: change from Pittsburgh sleep quality index scale at one week
timeFrame: 1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
measure: Interleukin 6
timeFrame: 1 day before treatment and 1 day after treatment
measure: change from the Epworth sleepiness scale at one week
timeFrame: one week
measure: change from Parkinson's disease sleep scale at one week
timeFrame: one week
measure: change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
timeFrame: one week
measure: change from Parkinson's disease quality of life scale one week
timeFrame: one week
measure: change from Hamilton depression scale at one week
timeFrame: one week
measure: change from Hamilton anxiety scale at one week
timeFrame: one week
measure: change from simple mental state scale at one week
timeFrame: one week
measure: change from Montreal cognitive assessment scale at one week
timeFrame: one week
measure: change from magnetic resonance imaging of the brain at one month
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
name: Xiuhua Li, MD
role: PRINCIPAL_INVESTIGATOR
References: