A Multicenter Clinical Study of rTMS for Parkinson's Disease

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: Routine treatment in Neurology and rTMS; Other: Routine treatment in Neurology

Study type: Interventional

Funder types: Other

Identifiers

NCT06009471

LCYJ-B06

Details and patient eligibility

About

Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.

Full description

According to the inclusion criteria, a total of 200 patients with Parkinson's disease were planned to be enrolled in each center, and randomly divided into control group (conventional treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4 weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks, respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were recorded.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hoehn-YAHR classification is between 1 and 2；
• Have a primary school education or above and can read the scale used in this study;
• MoCA score between 20 and 24, mild cognitive impairment ;
• Aged between 30 and 80, regardless of gender；
• Voluntarily participate and sign informed consent.

Exclusion criteria

• patients with cerebrovascular accident, craniocerebral injury and other diseases affecting muscle tension;
• patients with serious mental disorders and cognitive disorders who cannot cooperate with assessment;
• patients with severe liver, kidney, heart dysfunction and severe physical disorders;
• Implanted devices such as pacemakers are installed inside the body;
• drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;
• Have a history of epilepsy;
• Women during pregnancy and breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Control group

Active Comparator group

Description:

All participants were treated with routine treatment in Neurology.

Treatment:

Other: Routine treatment in Neurology

Experimental group

Experimental group

Description:

All participants were treated with routine treatment in Neurology and rTMS treatment. rTMS parameters were set to stimulate the site: bilateral primary motor cortex; Stimulus frequency :5Hz; Pulse number: 1000 pulses per day, 500 on the left and 500 on the right; Stimulus intensity :90% resting threshold; Coil: 70mm round coil; Once a day, 30 minutes each time, 5 days a week for 4 weeks

Treatment:

Device: Routine treatment in Neurology and rTMS