Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

Parkinson's Disease Clinical Trial

Official title:

Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06365190
• Other study ID #: AHMU-PD-rTMS
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Transcranial Magnetic Stimulation

Intervention

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.

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

Locations

Country	Name	City	State
China	Cognitive Neuropsychology Lab Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Levodopa equivalent dose	Different antiparkinsonian drugs converted to equivalent amounts of levodopa.	baseline; week 3; week 13;week 23;week 33