Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson's Disease; Transcranial Magnetic Stimulation
• Intervention / Treatment: Other: transcranial magnetic stimulation; Drug: Pharmacotherapy（antiparkinsonian drugs）

Detailed Description

This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease.

Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Cognitive Neuropsychology Lab Anhui Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Meet the Chinese diagnostic criteria for Parkinson's disease (2016 version);
• Age ≥ 40 years old;
• Stable use of medication for at least 2 weeks;
• MMSE score ≧ 24 points;
• Those who can cooperate to complete the experiment; (6) Those who have not received rTMS treatment in the past.

Exclusion Criteria:

• History or clinical symptoms of other serious mental illnesses (such as major depression, psychosis, or obsessive-compulsive disorder);
• Severe organic brain defects on T1 or T2 images;
• History or unknown epilepsy Cause of loss of consciousness;
• Head injury, stroke or other neurological disease;
• Immovable metal objects on or around the head;
• History of drug abuse within the past 6 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cTBS group; On the basis of drug treatment, a course of TBS treatment is performed every eight weeks.	Other: transcranial magnetic stimulation; During treatment, the patient underwent cTBS targeting the left SMA for 14 consecutive days. Each treatment day comprised three rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period.
Other: Drug group; Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment	Drug: Pharmacotherapy（antiparkinsonian drugs）; Anti-Parkinson's disease drugs include compound levodopa, dopamine receptor agonists, monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, etc. Take dopaminergic agents regularly, with follow-up every 8 weeks including medication guidance and symptom assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale III scores	This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.	baseline; week 3; week 13;week 23;week 33

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoehn-Yahr(H-Y) stage	It ranges from 1 to 5, and is evaluated based on the range of symptoms involved and whether balance is impaired in PD patients. The higher the score, the more severe the severity.	baseline; week 3; week 13;week 23;week 33
Levodopa equivalent dose	Different antiparkinsonian drugs converted to equivalent amounts of levodopa.	baseline; week 3; week 13;week 23;week 33

Collaborators and Investigators

• Sponsor: Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Transcranial Magnetic Stimulation
• 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; Anti-Dyskinesia Agents; Antiparkinson Agents
• Other Study ID Numbers: AHMU-PD-rTMS

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