Clinical trial NCT06009471: A Multicenter Clinical Study of rTMS for Parkinson's Disease
Official title: A Multicenter Clinical Study of rTMS for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
repetitive transcranial magnetic stimulation(rTMS)
Unified Parkinson's Disease Rating Scale (UPDRS)
Montreal Cognitive Assessment Scale (MoCA)
activity of daily living(ADL)
PD Sleep Scale (PDSS)
King's Parkinson's Pain Assessment (KPPS)
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 200 patients with Parkinson's disease were enrolled in each center and randomly divided into control group (routine treatment) and observation group (routine treatment +rTMS).
Primary purpose: TREATMENT

Brief summary: Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.

Detailed description: According to the inclusion criteria, a total of 200 patients with Parkinson's disease were planned to be enrolled in each center, and randomly divided into control group (conventional treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4 weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks, respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were recorded.

Eligibility criteria: Inclusion Criteria:

* Hoehn-YAHR classification is between 1 and 2；
* Have a primary school education or above and can read the scale used in this study;
* MoCA score between 20 and 24, mild cognitive impairment ;
* Aged between 30 and 80, regardless of gender；
* Voluntarily participate and sign informed consent.

Exclusion Criteria:

* patients with cerebrovascular accident, craniocerebral injury and other diseases affecting muscle tension;
* patients with serious mental disorders and cognitive disorders who cannot cooperate with assessment;
* patients with severe liver, kidney, heart dysfunction and severe physical disorders;
* Implanted devices such as pacemakers are installed inside the body;
* drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;
* Have a history of epilepsy;
* Women during pregnancy and breastfeeding.

Primary outcomes:
measure: Unified Parkinson's disease rating Scale （UPDRS）
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
measure: Montreal Cognitive Assessment Scale (MoCA)
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
measure: King's Parkinson's Pain Assessment (KPPS)
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
measure: PD Sleep Scale (PDSS)
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
measure: Activities of daily living Assessment - Barthel
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Secondary outcomes:
measure: Hamilton Depression Scale (HAMD)
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Other outcomes:
Locations:
city: Nantong
country: China
facility: rTMS
state: Jiangsu
Study officials:
References: