Clinical trial NCT06383247: The Efficacy and Safety of Precision REpetitive Transcranial Magnetic Stimulation in Alleviating Motor Symptom in Parkinson's Disease
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Trial (PRESS-PD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Transcranial Magenetic Stimualtion
Supplementary Motor Area
Keywords: Parkinson Disease
transcranial magenetic stimualtion
supplementary motor area
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 290
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.

Detailed description: This is a multi-center, double-blind, randomized controlled study that will be implemented in multiple hospital centers in China. In this study, the supplementary motor area (SMA) of the dominant hemisphere was selected as the stimulation target, and continuous theta burst stimulation (cTBS) sequence contact stimulation was used for a course of continuous stimulation for 7 days to observe the changes in clinical symptoms before and after the intervention.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 40 years old;
2. Meet the diagnostic criteria for idiopathic Parkinson's disease (MDS Diagnostic Criteria for Parkinson's Disease (2015 Edition))\[1\];
3. Have no history of drug adjustment within 4 weeks before treatment and the entire study period;
4. The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4;
5. MMSE ≥22，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

Exclusion Criteria:

1. Previously head MRI/CT was focal brain injury or severe leukoencephalopathy (Fazekas grade 3 and above);
2. Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
3. Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
4. There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
5. The person has a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
6. Diagnosed with a neuropsychiatric disorder other than PD
7. Have a history of drug abuse or drug use;
8. Participants in any clinical trial within the previous 6 month;
9. Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;
10. Other conditions deemed unsuitable for inclusion by the investigator.

Primary outcomes:
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores
timeFrame: baseline; day 8; week 5;week 9
Secondary outcomes:
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores
timeFrame: baseline; day 8; week 5;week 9
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores
timeFrame: baseline; day 8; week 5;week 9
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores
timeFrame: baseline; day 8; week 5;week 9
measure: Hoehn-Yahr(H-Y) scale
timeFrame: baseline; day 8; week 5;week 9
measure: The timed up and go test (TUG)
timeFrame: baseline; day 8; week 5;week 9
measure: 20 meters walking
timeFrame: baseline; day 8; week 5;week 9
measure: Non-motor symptom scale（NMSS）
timeFrame: baseline; day 8; week 5;week 9
measure: Parkinson's Disease questionnaire-39 items（PDQ-39）
timeFrame: baseline; day 8; week 5;week 9
measure: Hamilton Depression Scale-17（HAMD-17）
timeFrame: baseline; day 8; week 5;week 9
measure: Hamilton Anxiety Scale（HAMA）
timeFrame: baseline; day 8; week 5;week 9
measure: Pittsburgh sleep quality index（PSQI）
timeFrame: baseline; day 8; week 5;week 9
measure: Mini-Mental State Examination（MMSE）
timeFrame: baseline; day 8; week 5;week 9
measure: Clinical Global Impression（CGI）
timeFrame: baseline; day 8; week 5;week 9
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Panpan Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: