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

Qianfoshan Hospital

Status: Unknown

Conditions: Sleep Disorder; Parkinson Disease; Repetitive Transcranial Magnetic Stimulation

Treatments: Device: Ultra-low frequency repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04804176

ULFRTMS-S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

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

Active Comparator group

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.

Treatment:

Device: Ultra-low frequency repetitive transcranial magnetic stimulation

GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation

Active Comparator group

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

Treatment:

Device: Ultra-low frequency repetitive transcranial magnetic stimulation

the control group

Sham Comparator group

Description:

The instrument is not working, only in exhaust mode.

Treatment:

Device: Ultra-low frequency repetitive transcranial magnetic stimulation