A Multicenter Clinical Study of rTMS for Parkinson's Disease

NCT ID: NCT06009471

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-08-31

Brief Summary

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.

Detailed 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.

Conditions

Parkinson's Disease

Study Design

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

Study Groups

Control group

All participants were treated with routine treatment in Neurology.

Group Type: ACTIVE_COMPARATOR

Routine treatment in Neurology

Intervention Type: OTHER

Routine treatment in Neurology department, including drug treatment,etc.

Experimental group

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

Group Type: EXPERIMENTAL

Routine treatment in Neurology and rTMS

Intervention Type: DEVICE

Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability

Interventions

Routine treatment in Neurology

Routine treatment in Neurology department, including drug treatment,etc.

Intervention Type: OTHER

Routine treatment in Neurology and rTMS

Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

rTMS

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Aisong Guo

Role: CONTACT

guoasg@ntu.edu.cn

15851300188

Facility Contacts

Aisong Guo

Role: primary

guoasg@ntu.edu.cn

15851300188

Other Identifiers

LCYJ-B06

Identifier Type: -

Identifier Source: org_study_id