Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

NCT06365190 | Active Not Recruiting

• 1 other identifier: AHMU-PD-rTMS
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcranial Magnetic Stimulation; Parkinson's Disease

Keywords

Transcranial Magnetic Stimulation; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hoehn-Yahr(H-Y) stage

  baseline; week 3; week 13;week 23;week 33

• Levodopa equivalent dose

  baseline; week 3; week 13;week 23;week 33

Study Arms (2)

cTBS group

EXPERIMENTAL

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

Other: transcranial magnetic stimulation

Drug group

OTHER

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

Drug: Pharmacotherapy（antiparkinsonian drugs）

Interventions

transcranial magnetic stimulation 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.

cTBS group

Pharmacotherapy（antiparkinsonian drugs） 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

Drug group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, 230022, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 15, 2024
• Study Start: April 6, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)