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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04804176
• Other study ID #: ULFRTMS-S
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: April 20, 2022

Study information

• Verified date: March 2021
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 99
• Est. completion date: April 20, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Parkinson Disease
• Repetitive Transcranial Magnetic Stimulation
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from length of sleep at one week	Sleep duration was monitored by polysomnography.It's measured in minutes.	one week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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