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

Primary Purpose

Repetitive Transcranial Magnetic Stimulation, Parkinson Disease, Sleep Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultra-low frequency repetitive transcranial magnetic stimulation
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Repetitive Transcranial Magnetic Stimulation focused on measuring repetitive transcranial magnetic stimulation, Parkinson's disease, sleep disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Shandong First Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation

GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation

the control group

Arm Description

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.

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

The instrument is not working, only in exhaust mode.

Outcomes

Primary Outcome Measures

change from length of sleep at one week
Sleep duration was monitored by polysomnography.It's measured in minutes.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2021
Last Updated
March 20, 2021
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04804176
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
April 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Repetitive Transcranial Magnetic Stimulation, Parkinson Disease, Sleep Disorder
Keywords
repetitive transcranial magnetic stimulation, Parkinson's disease, sleep disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
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
Arm Title
the control group
Arm Type
Sham Comparator
Arm Description
The instrument is not working, only in exhaust mode.
Intervention Type
Device
Intervention Name(s)
Ultra-low frequency repetitive transcranial magnetic stimulation
Intervention Description
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
Primary Outcome Measure Information:
Title
change from length of sleep at one week
Description
Sleep duration was monitored by polysomnography.It's measured in minutes.
Time Frame
one week
Title
change from ratio of stage 3 sleep in total sleep at one week
Description
The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.
Time Frame
one week
Title
change from limb movement of sleep at one week
Description
The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.
Time Frame
one week
Title
change from nocturnal arousal frequency at one week
Description
The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.
Time Frame
one week
Title
change from Pittsburgh sleep quality index scale at one week
Description
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.
Time Frame
1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
Title
Interleukin 6
Description
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.
Time Frame
1 day before treatment and 1 day after treatment
Title
change from the Epworth sleepiness scale at one week
Description
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.
Time Frame
one week
Title
change from Parkinson's disease sleep scale at one week
Description
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.
Time Frame
one week
Title
change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
Description
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.
Time Frame
one week
Title
change from Parkinson's disease quality of life scale one week
Description
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.
Time Frame
one week
Title
change from Hamilton depression scale at one week
Description
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.
Time Frame
one week
Title
change from Hamilton anxiety scale at one week
Description
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.
Time Frame
one week
Title
change from simple mental state scale at one week
Description
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.
Time Frame
one week
Title
change from Montreal cognitive assessment scale at one week
Description
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.
Time Frame
one week
Title
change from magnetic resonance imaging of the brain at one month
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuhua Li, MD
Organizational Affiliation
Qianfoshan Hospital,The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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