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

NCT ID: NCT04804176

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2022-04-20

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.

Conditions

Repetitive Transcranial Magnetic Stimulation; Parkinson Disease; Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ultra-low frequency repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.

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

Group Type: ACTIVE_COMPARATOR

Ultra-low frequency repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.

the control group

The instrument is not working, only in exhaust mode.

Group Type: SHAM_COMPARATOR

Ultra-low frequency repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.

Interventions

Ultra-low frequency repetitive transcranial magnetic stimulation

Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lili Cao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuhua Li, MD

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University

Locations

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Other Identifiers

ULFRTMS-S

Identifier Type: -

Identifier Source: org_study_id