A Multicenter Clinical Study of rTMS for Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Routine treatment in Neurology; Device: Routine treatment in Neurology and rTMS

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aisong Guo; Phone Number: 15851300188; Email: guoasg@ntu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • rTMS
      • Contact: Aisong Guo; Phone Number: 15851300188; Email: guoasg@ntu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; All participants were treated with routine treatment in Neurology.	Other: Routine treatment in Neurology; Routine treatment in Neurology department, including drug treatment,etc.
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's disease rating Scale （UPDRS）	16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Montreal Cognitive Assessment Scale (MoCA)	Full score of 30 points,>=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of<10.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
King's Parkinson's Pain Assessment (KPPS)	Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
PD Sleep Scale (PDSS)	Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Activities of daily living Assessment - Barthel	The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Scale (HAMD)	Evaluate depressive status, including 14 5-level scoring items (0-4 points) and 10 3-level scoring items (0-2 points). Score<8, no depression; 8 to 35 points, may be mild or moderate depression 35 points, may be severe depression.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Hamilton Anxiety Scale (HAMA)	Include 14 projects. All items of HAMA adopt a 5-level scoring method of 0~4 points, and the criteria of each level are: (0) is Asymptomatic; (1) Light; (2) Moderate; (3) Heavy; (4) Extremely heavy. The total score of HAMA can better reflect the severity of anxiety symptoms. The total score can be used to evaluate the severity of anxiety symptoms and evaluate the effectiveness of various drugs and psychological interventions in patients with anxiety and depression disorders. According to the data provided by the collaborative group of the Chinese scale, if the total score exceeds 29 points, it may be severe anxiety; Above 21 points, there must be obvious anxiety; If the score exceeds 14, there must be anxiety; If the score exceeds 7, there may be anxiety; If the score is less than 7, there are no symptoms of anxiety. Generally speaking, the total score of HAMA is higher than 14 points, indicating clinically significant anxiety symptoms for the evaluated subject.	The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's disease; repetitive transcranial magnetic stimulation(rTMS); Unified Parkinson's Disease Rating Scale (UPDRS); Montreal Cognitive Assessment Scale (MoCA); activity of daily living(ADL); PD Sleep Scale (PDSS); King's Parkinson's Pain Assessment (KPPS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: LCYJ-B06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No