Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

NCT ID: NCT06365190

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2024-07-31

Brief Summary

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.

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.

Conditions

Transcranial Magnetic Stimulation; Parkinson's Disease

Study Design

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

Study Groups

cTBS group

On the basis of drug treatment, a course of TBS treatment is performed every eight weeks.

Group Type: EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type: OTHER

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.

Drug group

Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment

Group Type: OTHER

Pharmacotherapy（antiparkinsonian drugs）

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

AHMU-PD-rTMS

Identifier Type: -

Identifier Source: org_study_id