Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease

Study on the Mode and Mechanism of Ultra-low Frequency Repetitive Transcranial Magnetic Stimulation for Sleep Disorders in Patients With Parkinson's Disease

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Sleep Disorder; Repetitive Transcranial Magnetic Stimulation
• Intervention / Treatment: Device: Ultra-low frequency repetitive transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation; The study used 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS.	Device: Ultra-low frequency repetitive transcranial magnetic stimulation; Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
Active Comparator: GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation; The study used GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS	Device: Ultra-low frequency repetitive transcranial magnetic stimulation; Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
Sham Comparator: the control group; The instrument is not working, only in exhaust mode.	Device: Ultra-low frequency repetitive transcranial magnetic stimulation; Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from length of sleep at one week	Sleep duration was monitored by polysomnography.It's measured in minutes.	one week
change from ratio of stage 3 sleep in total sleep at one week	The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.	one week
change from limb movement of sleep at one week	The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.	one week
change from nocturnal arousal frequency at one week	The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.	one week
change from Pittsburgh sleep quality index scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 2L, and the higher the score, the worse the sleep quality.	1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
Interleukin 6	It plays an important role in central nervous system diseases. In PD, the increase of IL-6 is the body's self-defense mechanism to protect neurons, and the change of IL-6 in peripheral blood can reflect the change of injury aggravation and recovery.It is also associated with psychiatric symptoms, and IL-6 is elevated in major depression.	1 day before treatment and 1 day after treatment
change from the Epworth sleepiness scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The scale has an overall score range of 0 to 24, with higher scores indicating more severe sleepiness.	one week
change from Parkinson's disease sleep scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 150. The higher the score, the better the sleep.	one week
change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 260, and the higher the score, the more severe the symptoms were.	one week
change from Parkinson's disease quality of life scale one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 156, and the higher the score, the worse the quality of life.	one week
change from Hamilton depression scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 96, and the higher the score, the more severe the depression was.	one week
change from Hamilton anxiety scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 56, and the higher the score, the more serious the anxiety.	one week
change from simple mental state scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.	one week
change from Montreal cognitive assessment scale at one week	The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.	one week
change from magnetic resonance imaging of the brain at one month	The ADC values of sleep-related brain tissues were measured by diffusion weighted magnetic resonance imaging of the brain.Compare the difference between the measured results on both sides of the same site and record the difference.	one month

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Xiuhua Li, MD, Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): April 20, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: repetitive transcranial magnetic stimulation; sleep disorder; Parkinson's disease
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease; Parkinson Disease; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: ULFRTMS-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No