Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2019
CompletedFirst Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2022
CompletedMarch 24, 2021
March 1, 2021
2 years
March 8, 2021
March 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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
Study Arms (3)
5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation
ACTIVE COMPARATORThe 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.
GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation
ACTIVE COMPARATORThe 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 control group
SHAM COMPARATORThe instrument is not working, only in exhaust mode.
Interventions
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuhua Li, MD
Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 18, 2021
Study Start
December 20, 2019
Primary Completion
December 20, 2021
Study Completion
April 20, 2022
Last Updated
March 24, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share